Trial Outcomes & Findings for Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis (NCT NCT04004416)

Last Updated: 2026-06-17

Results Overview

Change in brain activity in the medial frontal cortex after being given lorazepam, a medication that changes the activity of GABAergic neurons. Results reflect the difference/change in brain signal between the lorazepam scan and the placebo scan. BOLD change in the dorsomedial prefrontal cortex (dmPFC) was summarized using MATLAB (MatrixLaboratory)'s SPM (Statistical Parametric Mapping) package for eigenvariate extraction, which extracts the first principal component of the voxel time series within an region of interest (ROI). The resulting values are in arbitrary units (AU) reflecting variance-normalized signal after temporal filtering and serial correlation correction, which removes absolute signal scaling. While AU values are not directly interpretable as percent signal change, they preserve relative differences in BOLD change across conditions and are appropriate for statistical comparison.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

143 participants

Primary outcome timeframe

Approximately 28 days

Results posted on

2026-06-17

Participant Flow

Participants were targeted for recruitment from clinical sites (ex, Program for Risk Evaluation and Prevention (PREP) clinic) using medical record review and/or clinician referral. They were also recruited through research registries (ex, UMHealthResearch.org, departmental psychiatric research registry), via community advertisements (ex, flyers), internet sources such as social media (ex, Facebook/Instagram/Google AdWords paid campaigns), and email blasts.

Of the 240 participants consented, 97 were determined to be ineligible for the trial, leaving 143 total enrolled (17 Early Psychosis patients, 35 Schizophrenia or Schizoaffective disorder patients, 30 Bipolar disorder patients, 61 Healthy controls). Of those 143 enrolled, 24 participants were never randomized to a treatment order. 8 withdrew; 9 were lost to follow-up, and 7 were removed due to physician decision (ex, a change in participant eligibility).

Participant milestones

Participant milestones
Measure	Early Psychosis Patients - Lorazepam 0.01 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Lorazepam 0.02 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Placebo First, Lorazepam 0.01 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Placebo First, Lorazepam 0.02 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Lorazepam 0.01 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.01 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.02 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Placebo First, Lorazepam 0.01 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Placebo First, Lorazepam 0.02 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.
First fMRI Visit STARTED	4	4	5	3	6	7	7	7	6	5	7	5	13	14	14	12
First fMRI Visit COMPLETED	4	4	5	3	6	6	7	7	6	5	7	5	13	14	14	12
First fMRI Visit NOT COMPLETED	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Time Between fMRI Visits STARTED	4	4	5	3	6	6	7	7	6	5	7	5	13	14	14	12
Time Between fMRI Visits COMPLETED	2	3	4	3	6	6	6	6	6	5	7	5	13	13	11	12
Time Between fMRI Visits NOT COMPLETED	2	1	1	0	0	0	1	1	0	0	0	0	0	1	3	0
Second fMRI Visit STARTED	2	3	4	3	6	6	6	6	6	5	7	5	13	13	11	12
Second fMRI Visit COMPLETED	2	3	4	3	6	6	6	6	6	5	7	5	13	13	11	12
Second fMRI Visit NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Psychosis Patients - Lorazepam 0.01 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Lorazepam 0.02 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Placebo First, Lorazepam 0.01 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.02 mg/kg First, Placebo Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Placebo First, Lorazepam 0.01 mg/kg Second Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.
First fMRI Visit Physician Decision	0	0	0	1	0	0	0	0
Time Between fMRI Visits Physician Decision	2	1	1	0	0	0	0	1
Time Between fMRI Visits Lost to Follow-up	0	0	0	0	0	1	0	1
Time Between fMRI Visits Withdrawal by Subject	0	0	0	0	1	0	0	1
Time Between fMRI Visits Adverse Event	0	0	0	0	0	0	1	0

Baseline Characteristics

Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Psychosis Patients - Lorazepam 0.01 mg/kg First, Placebo Second n=4 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Lorazepam 0.02 mg/kg First, Placebo Second n=4 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Placebo First, Lorazepam 0.01 mg/kg Second n=5 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Placebo First, Lorazepam 0.02 mg/kg Second n=3 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg First, Placebo Second n=6 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second n=7 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second n=7 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second n=7 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Lorazepam 0.01 mg/kg First, Placebo Second n=6 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second n=5 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second n=7 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second n=5 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.01 mg/kg First, Placebo Second n=13 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.02 mg/kg First, Placebo Second n=14 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Placebo First, Lorazepam 0.01 mg/kg Second n=14 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Placebo First, Lorazepam 0.02 mg/kg Second n=12 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Total n=119 Participants Total of all reporting groups
Age, Continuous	19.21 years STANDARD_DEVIATION 2.31 • n=9 Participants	23.08 years STANDARD_DEVIATION 3.57 • n=27 Participants	26.27 years STANDARD_DEVIATION 5.17 • n=267 Participants	21.61 years STANDARD_DEVIATION 8.86 • n=265 Participants	28.64 years STANDARD_DEVIATION 11.47 • n=568 Participants	40.48 years STANDARD_DEVIATION 9.55 • n=22 Participants	35.68 years STANDARD_DEVIATION 13.63 • n=23 Participants	39.39 years STANDARD_DEVIATION 9.19 • n=22 Participants	33.18 years STANDARD_DEVIATION 13.80 • n=178 Participants	34.25 years STANDARD_DEVIATION 9.73 • n=116 Participants	34.75 years STANDARD_DEVIATION 10.66 • n=2 Participants	44.97 years STANDARD_DEVIATION 11.92 • n=4 Participants	32.15 years STANDARD_DEVIATION 12.67 • n=190 Participants	30.36 years STANDARD_DEVIATION 10.04 • n=19 Participants	34.39 years STANDARD_DEVIATION 14.04 • n=18 Participants	30.51 years STANDARD_DEVIATION 11.76 • n=18 Participants	32.56 years STANDARD_DEVIATION 11.86 • n=14 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	2 Participants n=27 Participants	3 Participants n=267 Participants	2 Participants n=265 Participants	3 Participants n=568 Participants	4 Participants n=22 Participants	4 Participants n=23 Participants	3 Participants n=22 Participants	3 Participants n=178 Participants	3 Participants n=116 Participants	4 Participants n=2 Participants	3 Participants n=4 Participants	8 Participants n=190 Participants	8 Participants n=19 Participants	8 Participants n=18 Participants	7 Participants n=18 Participants	67 Participants n=14 Participants
Sex: Female, Male Male	2 Participants n=9 Participants	2 Participants n=27 Participants	2 Participants n=267 Participants	1 Participants n=265 Participants	3 Participants n=568 Participants	3 Participants n=22 Participants	3 Participants n=23 Participants	4 Participants n=22 Participants	3 Participants n=178 Participants	2 Participants n=116 Participants	3 Participants n=2 Participants	2 Participants n=4 Participants	5 Participants n=190 Participants	6 Participants n=19 Participants	6 Participants n=18 Participants	5 Participants n=18 Participants	52 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	3 Participants n=568 Participants	1 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	1 Participants n=190 Participants	0 Participants n=19 Participants	1 Participants n=18 Participants	1 Participants n=18 Participants	7 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=9 Participants	4 Participants n=27 Participants	5 Participants n=267 Participants	3 Participants n=265 Participants	3 Participants n=568 Participants	6 Participants n=22 Participants	7 Participants n=23 Participants	7 Participants n=22 Participants	6 Participants n=178 Participants	5 Participants n=116 Participants	7 Participants n=2 Participants	5 Participants n=4 Participants	12 Participants n=190 Participants	14 Participants n=19 Participants	13 Participants n=18 Participants	11 Participants n=18 Participants	112 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=14 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=14 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	1 Participants n=27 Participants	1 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	1 Participants n=2 Participants	0 Participants n=4 Participants	2 Participants n=190 Participants	2 Participants n=19 Participants	4 Participants n=18 Participants	6 Participants n=18 Participants	18 Participants n=14 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=14 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	1 Participants n=265 Participants	0 Participants n=568 Participants	1 Participants n=22 Participants	1 Participants n=23 Participants	1 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	1 Participants n=190 Participants	3 Participants n=19 Participants	1 Participants n=18 Participants	1 Participants n=18 Participants	10 Participants n=14 Participants
Race (NIH/OMB) White	3 Participants n=9 Participants	3 Participants n=27 Participants	4 Participants n=267 Participants	2 Participants n=265 Participants	5 Participants n=568 Participants	5 Participants n=22 Participants	5 Participants n=23 Participants	6 Participants n=22 Participants	6 Participants n=178 Participants	5 Participants n=116 Participants	6 Participants n=2 Participants	4 Participants n=4 Participants	10 Participants n=190 Participants	9 Participants n=19 Participants	7 Participants n=18 Participants	4 Participants n=18 Participants	84 Participants n=14 Participants
Race (NIH/OMB) More than one race	1 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	1 Participants n=568 Participants	1 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	1 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	2 Participants n=18 Participants	1 Participants n=18 Participants	7 Participants n=14 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=14 Participants
Region of Enrollment United States	4 Participants n=9 Participants	4 Participants n=27 Participants	5 Participants n=267 Participants	3 Participants n=265 Participants	6 Participants n=568 Participants	7 Participants n=22 Participants	7 Participants n=23 Participants	7 Participants n=22 Participants	6 Participants n=178 Participants	5 Participants n=116 Participants	7 Participants n=2 Participants	5 Participants n=4 Participants	13 Participants n=190 Participants	14 Participants n=19 Participants	14 Participants n=18 Participants	12 Participants n=18 Participants	119 Participants n=14 Participants

PRIMARY outcome

Timeframe: Approximately 28 days

Population: Both fMRI scans are necessary to calculate the difference/change in brain signal between the lorazepam scan and the placebo scan, so participants were not analyzed if they did not provide usable data at both fMRIs. Reasons for unusable data included withdrawal (for example, due to no longer being eligible), loss to follow-up, unresponsiveness during the image viewing task, excessive movement, and fMRI image distortion.

Outcome measures

Outcome measures
Measure	Early Psychosis Patients - Lorazepam 0.01 mg/kg n=6 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Lorazepam 0.02 mg/kg n=6 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Placebo n=12 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg n=11 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg n=10 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Placebo n=21 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Lorazepam 0.01 mg/kg n=13 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Lorazepam 0.02 mg/kg n=10 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Placebo n=23 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.01 mg/kg n=24 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.02 mg/kg n=21 Participants Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Placebo n=45 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.
Blood Oxygen Level Dependent (BOLD) Change in Medial Frontal Cortex While Viewing Affective Pictures	-0.174 AU Standard Deviation 0.183	-0.037 AU Standard Deviation 0.138	-0.177 AU Standard Deviation 0.209	-0.167 AU Standard Deviation 0.12	-0.046 AU Standard Deviation 0.169	-0.175 AU Standard Deviation 0.207	-0.112 AU Standard Deviation 0.185	-0.204 AU Standard Deviation 0.342	-0.186 AU Standard Deviation 0.213	-0.163 AU Standard Deviation 0.23	-0.08 AU Standard Deviation 0.195	-0.158 AU Standard Deviation 0.245

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 28 days

Levels of negative affect were calculated from a PCA of self-report scales: Psychological Stress Index (PSI9; 9-item, Min=0, Max=36, higher=more stress), negative emotions from Modified Differential Emotions Scale (mDES; 8-item subscale, Min=0, Max=32, higher=more negative emotion), Beck Depression Inventory (BDI; 21-item, Min=0, Max=63, higher=more depression). Each measure was completed twice (pre-placebo and pre-drug). The PCA used the prcomp function in R (version 4.5.3), with variables from each scale centered and scaled to unit variance. The 1st principal component of PCA was used as index of general negative affect. This component explained 79% of the total variance across the 6 input measures. Individual component scores were extracted for each participant (Range Min=-3.352, Max=7.067, arbitrary units, higher values=more negative affect/worse outcome).

Outcome measures

Outcome measures
Measure	Early Psychosis Patients - Lorazepam 0.01 mg/kg n=6 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Lorazepam 0.02 mg/kg n=6 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Early Psychosis Patients - Placebo n=12 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg n=11 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg n=10 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Schizophrenia or Schizoaffective Disorder Patients - Placebo n=21 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Lorazepam 0.01 mg/kg n=13 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Lorazepam 0.02 mg/kg n=10 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Bipolar Disorder Patients - Placebo n=23 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.01 mg/kg n=24 Participants Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Lorazepam 0.02 mg/kg n=21 Participants Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.	Healthy Controls - Placebo n=45 Participants Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI.
Levels of Negative Affect	0.42 Principal Component Analysis Score Standard Deviation 1.4	0.71 Principal Component Analysis Score Standard Deviation 2.55	0.57 Principal Component Analysis Score Standard Deviation 1.97	1.28 Principal Component Analysis Score Standard Deviation 2.87	2.02 Principal Component Analysis Score Standard Deviation 2.78	1.65 Principal Component Analysis Score Standard Deviation 2.79	0.71 Principal Component Analysis Score Standard Deviation 2.32	0.26 Principal Component Analysis Score Standard Deviation 1.35	0.52 Principal Component Analysis Score Standard Deviation 1.93	-1.13 Principal Component Analysis Score Standard Deviation 1.32	-1.25 Principal Component Analysis Score Standard Deviation 0.94	-1.19 Principal Component Analysis Score Standard Deviation 1.13

Adverse Events

Lorazepam 0.01 mg/kg Window

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Lorazepam 0.02 mg/kg Window

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Window

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lorazepam 0.01 mg/kg Window n=57 participants at risk Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Lorazepam 0.01 mg/kg was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration.	Lorazepam 0.02 mg/kg Window n=56 participants at risk Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Lorazepam 0.02 mg/kg was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration.	Placebo Window n=114 participants at risk Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Placebo was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration.
Psychiatric disorders Hospitalization	1.8% 1/57 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	1.8% 1/56 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	0.00% 0/114 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.

Other adverse events

Other adverse events
Measure	Lorazepam 0.01 mg/kg Window n=57 participants at risk Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Lorazepam 0.01 mg/kg was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration.	Lorazepam 0.02 mg/kg Window n=56 participants at risk Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Lorazepam 0.02 mg/kg was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration.	Placebo Window n=114 participants at risk Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Placebo was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration.
Gastrointestinal disorders Nausea	0.00% 0/57 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	0.00% 0/56 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	0.88% 1/114 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.
General disorders Dizziness	0.00% 0/57 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	3.6% 2/56 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	0.00% 0/114 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.
Nervous system disorders Incidental Finding	1.8% 1/57 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	5.4% 3/56 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	0.88% 1/114 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.
Psychiatric disorders Symptom worsening	0.00% 0/57 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	1.8% 1/56 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	1.8% 2/114 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/57 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	0.00% 0/56 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.	0.88% 1/114 • From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.

Additional Information

Stephan Taylor

University of Michigan

Phone: (734) 936-4955

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place