Trial Outcomes & Findings for Women's Post Traumatic Stress Disorder (PTSD) Research Study (NCT NCT01304940)

Last Updated: 2024-06-11

Results Overview

To calculate prepulse inhibition (PPI), first an O-EMG response score (O-EMG-R) for each trial was calculated. O-EMGR was measured in microvolts and each value was subjected to a square root transformation. For each participant, the mean O-EMG-R scores were calculated for both startle alone and prepulse + startle trials across the entire session. PPI is a ratio and was calculated by the formula below: PPI=(mean OEMG-R score on prepulse+startle trials-mean OEMG-R on Startle alone trials)/mean OEMG-R on startle alone trials. A negative value on this PPI ratio is indicative of greater prepulse inhibition. Means and SEs below reflect estimated means and SEs for the PTSD group and trauma control group from the ANOVA conducted with menstrual phase and the PTSD group X menstrual phase interaction included in the model.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

This measure was assessed twice for each participant, once in the midluteal phase of the menstrual cycle and once in the early follicular phase of the menstrual cycle, up to approximately 20 days apart.

Results posted on

2024-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	PTSD Group Individuals in this group meet criteria for PTSD as defined by DSM-IV	Trauma Control Group individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV
Overall Study STARTED	25	25
Overall Study Completed Study	25	25
Overall Study COMPLETED	22	25
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PTSD Group Individuals in this group meet criteria for PTSD as defined by DSM-IV	Trauma Control Group individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV
Overall Study not meet symptom severity requirement	3	0

Baseline Characteristics

Women's Post Traumatic Stress Disorder (PTSD) Research Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTSD Group n=22 Participants Individuals in this group meet criteria for PTSD as defined by DSM-IV	Trauma Control Group n=25 Participants individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=99 Participants	25 Participants n=107 Participants	47 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	22 Participants n=99 Participants	25 Participants n=107 Participants	47 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=99 Participants	25 Participants n=107 Participants	45 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	9 Participants n=99 Participants	11 Participants n=107 Participants	20 Participants n=206 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants	10 Participants n=107 Participants	15 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	22 Participants n=99 Participants	25 Participants n=107 Participants	47 Participants n=206 Participants
smokers	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants

PRIMARY outcome

Timeframe: This measure was assessed twice for each participant, once in the midluteal phase of the menstrual cycle and once in the early follicular phase of the menstrual cycle, up to approximately 20 days apart.

Population: all participants with valid psychophys data analyzed

Outcome measures

Outcome measures
Measure	PTSD Group n=22 Participants Individuals in this group meet criteria for PTSD as defined by DSM-IV	Trauma Control Group n=25 Participants individuals in this group do not meet criteria for any Axis I diagnosis as defined by DSM-IV
Prepulse Inhibition	-.19 proportion of change in OEMGR response Standard Error .04	-.31 proportion of change in OEMGR response Standard Error .04

Adverse Events

PTSD Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Trauma Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanne Pineles

VA ORD

Phone: 857-364-5906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place