Trial Outcomes & Findings for Persisting Effects of Psilocybin (NCT NCT02971605)

Last Updated: 2019-09-10

Results Overview

Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

1 day pre (baseline), 1 week post, and 1 month post session

Results posted on

2019-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Psilocybin Participants will be administered a 25 mg/70 kg dose of psilocybin Psilocybin: 25 mg/70 kg Psilocybin
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Psilocybin Participants will be administered a 25 mg/70 kg dose of psilocybin Psilocybin: 25 mg/70 kg Psilocybin
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Persisting Effects of Psilocybin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psilocybin n=13 Participants Participants will be administered a 25 mg/70 kg dose of psilocybin Psilocybin: 25 mg/70 kg Psilocybin
Age, Continuous	32.2 years STANDARD_DEVIATION 7.2 • n=39 Participants
Sex: Female, Male Female	8 Participants n=39 Participants
Sex: Female, Male Male	5 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	13 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Education Level High School/GED	1 Participants n=39 Participants
Education Level College	4 Participants n=39 Participants
Education Level Post-Graduate	8 Participants n=39 Participants

PRIMARY outcome

Timeframe: 1 day pre (baseline), 1 week post, and 1 month post session

Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.

Outcome measures

Outcome measures
Measure	Baseline n=12 Participants One day prior to psilocybin administration.	1-week Post Session n=12 Participants One week post psilocybin (25 mg/70 kg) administration.	1-month Post Session n=12 Participants One month post psilocybin (25 mg/70 kg) administration.
Amygdala Response to Stimuli in the Emotion Recognition Test L Amygdala contrast: Happy	0.835 BOLD percent signal change Standard Error 0.342	-0.759 BOLD percent signal change Standard Error 0.63	0.619 BOLD percent signal change Standard Error 0.449
Amygdala Response to Stimuli in the Emotion Recognition Test L Amygdala contrast: Neutral	0.794 BOLD percent signal change Standard Error 0.437	-0.825 BOLD percent signal change Standard Error 0.572	1.098 BOLD percent signal change Standard Error 0.582
Amygdala Response to Stimuli in the Emotion Recognition Test R Amygdala contrast: Happy	0.938 BOLD percent signal change Standard Error 0.388	-0.052 BOLD percent signal change Standard Error 0.431	0.749 BOLD percent signal change Standard Error 0.478
Amygdala Response to Stimuli in the Emotion Recognition Test R Amygdala contrast: Sad	0.927 BOLD percent signal change Standard Error 0.423	0.004 BOLD percent signal change Standard Error 0.37	0.816 BOLD percent signal change Standard Error 0.444
Amygdala Response to Stimuli in the Emotion Recognition Test R Amygdala contrast: Fearful	0.979 BOLD percent signal change Standard Error 0.424	-0.254 BOLD percent signal change Standard Error 0.481	0.617 BOLD percent signal change Standard Error 0.563
Amygdala Response to Stimuli in the Emotion Recognition Test R Amygdala contrast: Angry	0.834 BOLD percent signal change Standard Error 0.449	-0.028 BOLD percent signal change Standard Error 0.39	0.689 BOLD percent signal change Standard Error 0.454
Amygdala Response to Stimuli in the Emotion Recognition Test L Amygdala contrast: Sad	0.503 BOLD percent signal change Standard Error 0.403	-0.514 BOLD percent signal change Standard Error 0.635	0.999 BOLD percent signal change Standard Error 0.563
Amygdala Response to Stimuli in the Emotion Recognition Test L Amygdala contrast: Fearful	0.525 BOLD percent signal change Standard Error 0.421	-0.928 BOLD percent signal change Standard Error 0.696	0.664 BOLD percent signal change Standard Error 0.584
Amygdala Response to Stimuli in the Emotion Recognition Test L Amygdala contrast: Angry	0.514 BOLD percent signal change Standard Error 0.357	-0.881 BOLD percent signal change Standard Error 0.703	1.131 BOLD percent signal change Standard Error 0.569
Amygdala Response to Stimuli in the Emotion Recognition Test R Amygdala contrast: Neutral	1.081 BOLD percent signal change Standard Error 0.428	-0.256 BOLD percent signal change Standard Error 0.358	0.719 BOLD percent signal change Standard Error 0.476

SECONDARY outcome

Timeframe: 1 day pre (baseline), 1 week post, and 1 month post session

Population: The Big Five Inventory (BFI) and the Tellegen Absorption Scale (TAS) were not administered at 1-week post, and were only administered at Baseline and 1-month post.

Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood). Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales Positive \& Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168) State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales Tellegen Absorption Scale (TAS): Range 0-34 Big Five Inventory (BFI): Range 1-5 on all subscales

Outcome measures

Outcome measures
Measure	Baseline n=12 Participants One day prior to psilocybin administration.	1-week Post Session n=12 Participants One week post psilocybin (25 mg/70 kg) administration.	1-month Post Session n=12 Participants One month post psilocybin (25 mg/70 kg) administration.
Change in Longitudinal Emotion and Mood Questionnaire Scores Depression (DASS)	1.82 score on a scale Standard Error 0.57	1.09 score on a scale Standard Error 0.73	1.64 score on a scale Standard Error 0.59
Change in Longitudinal Emotion and Mood Questionnaire Scores Stress (DASS)	4.91 score on a scale Standard Error 1.06	2.00 score on a scale Standard Error 0.60	3.27 score on a scale Standard Error 1.12
Change in Longitudinal Emotion and Mood Questionnaire Scores Amusement (DPES)	5.02 score on a scale Standard Error 0.31	5.60 score on a scale Standard Error 0.32	5.71 score on a scale Standard Error 0.31
Change in Longitudinal Emotion and Mood Questionnaire Scores Negative Affect (PANAS-X)	16.09 score on a scale Standard Error 1.00	12.36 score on a scale Standard Error 0.93	16.09 score on a scale Standard Error 0.80
Change in Longitudinal Emotion and Mood Questionnaire Scores Depression (POMS)	3.36 score on a scale Standard Error 0.81	0.55 score on a scale Standard Error 0.25	2.64 score on a scale Standard Error 1.03
Change in Longitudinal Emotion and Mood Questionnaire Scores Anger (POMS)	4.91 score on a scale Standard Error 1.34	2.18 score on a scale Standard Error 0.58	4.64 score on a scale Standard Error 0.98
Change in Longitudinal Emotion and Mood Questionnaire Scores Vigor (POMS)	19.09 score on a scale Standard Error 1.35	21.45 score on a scale Standard Error 1.77	22.09 score on a scale Standard Error 2.15
Change in Longitudinal Emotion and Mood Questionnaire Scores State Anxiety (STAI)	28.0 score on a scale Standard Error 2.41	22.82 score on a scale Standard Error 1.37	25.64 score on a scale Standard Error 2.56
Change in Longitudinal Emotion and Mood Questionnaire Scores Trait Anxiety (STAI)	31.36 score on a scale Standard Error 1.91	28.55 score on a scale Standard Error 1.32	25.64 score on a scale Standard Error 27.55
Change in Longitudinal Emotion and Mood Questionnaire Scores Agreeableness (BFI)	4.43 score on a scale Standard Error 0.099	—	4.33 score on a scale Standard Error 0.117
Change in Longitudinal Emotion and Mood Questionnaire Scores Conscientiousness (BFI)	3.82 score on a scale Standard Error 0.172	—	3.98 score on a scale Standard Error 0.159
Change in Longitudinal Emotion and Mood Questionnaire Scores Neuroticism (BFI)	1.82 score on a scale Standard Error 0.213	—	1.67 score on a scale Standard Error 0.175
Change in Longitudinal Emotion and Mood Questionnaire Scores Anxiety (DASS)	1.64 score on a scale Standard Error 1.07	1.64 score on a scale Standard Error 0.75	1.45 score on a scale Standard Error 0.90
Change in Longitudinal Emotion and Mood Questionnaire Scores Joy (DPES)	5.45 score on a scale Standard Error 0.21	6.02 score on a scale Standard Error 0.17	5.92 score on a scale Standard Error 0.21
Change in Longitudinal Emotion and Mood Questionnaire Scores Content (DPES)	5.62 score on a scale Standard Error 0.24	6.27 score on a scale Standard Error 0.16	6.13 score on a scale Standard Error 0.23
Change in Longitudinal Emotion and Mood Questionnaire Scores Pride (DPES)	5.42 score on a scale Standard Error 0.22	5.96 score on a scale Standard Error 0.14	5.95 score on a scale Standard Error 0.18
Change in Longitudinal Emotion and Mood Questionnaire Scores Love (DPES)	5.61 score on a scale Standard Error 0.17	5.92 score on a scale Standard Error 0.25	5.98 score on a scale Standard Error 0.17
Change in Longitudinal Emotion and Mood Questionnaire Scores Compassion (DPES)	5.75 score on a scale Standard Error 0.31	6.25 score on a scale Standard Error 0.26	6.00 score on a scale Standard Error 0.30
Change in Longitudinal Emotion and Mood Questionnaire Scores Awe (DPES)	5.52 score on a scale Standard Error 0.26	6.06 score on a scale Standard Error 0.22	5.88 score on a scale Standard Error 0.24
Change in Longitudinal Emotion and Mood Questionnaire Scores Positive Affect (PANAS-X)	38.18 score on a scale Standard Error 1.41	40.64 score on a scale Standard Error 1.28	40.18 score on a scale Standard Error 1.92
Change in Longitudinal Emotion and Mood Questionnaire Scores Tension (POMS)	4.82 score on a scale Standard Error 1.22	1.73 score on a scale Standard Error 0.49	3.82 score on a scale Standard Error 1.19
Change in Longitudinal Emotion and Mood Questionnaire Scores Fatigue (POMS)	4.09 score on a scale Standard Error 1.37	2.27 score on a scale Standard Error 1.21	2.72 score on a scale Standard Error 1.06
Change in Longitudinal Emotion and Mood Questionnaire Scores Confusion (POMS)	5.55 score on a scale Standard Error 1.19	4.27 score on a scale Standard Error 0.79	4.72 score on a scale Standard Error 1.21
Change in Longitudinal Emotion and Mood Questionnaire Scores Mood Disturbance (POMS)	3.64 score on a scale Standard Error 5.67	-10.5 score on a scale Standard Error 3.23	-3.55 score on a scale Standard Error 6.19
Change in Longitudinal Emotion and Mood Questionnaire Scores Extraversion (BFI)	3.46 score on a scale Standard Error 0.190	—	3.69 score on a scale Standard Error 0.183
Change in Longitudinal Emotion and Mood Questionnaire Scores Openness (BFI)	4.17 score on a scale Standard Error 0.129	—	4.22 score on a scale Standard Error 0.151
Change in Longitudinal Emotion and Mood Questionnaire Scores Absorption (TAS)	0.98 score on a scale Standard Error 0.176	—	1.31 score on a scale Standard Error 0.233

SECONDARY outcome

Timeframe: 1 day pre (baseline), 1 week post, and 1 month post session

These tasks measure emotional responding that may be altered by psilocybin. Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images. Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor. Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative.

Outcome measures

Outcome measures
Measure	Baseline n=12 Participants One day prior to psilocybin administration.	1-week Post Session n=12 Participants One week post psilocybin (25 mg/70 kg) administration.	1-month Post Session n=12 Participants One month post psilocybin (25 mg/70 kg) administration.
Change in Emotional Functioning Task Accuracy Emotion recognition task: Happy	92.6 percentage of correct responses Standard Error 2.7	95.8 percentage of correct responses Standard Error 2.1	97.9 percentage of correct responses Standard Error 1.5
Change in Emotional Functioning Task Accuracy Emotion recognition task: Sad	95.7 percentage of correct responses Standard Error 2.1	93.8 percentage of correct responses Standard Error 2.5	94.8 percentage of correct responses Standard Error 2.3
Change in Emotional Functioning Task Accuracy Emotion recognition task: Angry	97.9 percentage of correct responses Standard Error 1.5	95.8 percentage of correct responses Standard Error 2.1	99.0 percentage of correct responses Standard Error 1.0
Change in Emotional Functioning Task Accuracy Emotion discrimination: Shapes (Control)	97.0 percentage of correct responses Standard Error 1.0	97.0 percentage of correct responses Standard Error 1.0	95.0 percentage of correct responses Standard Error 1.3
Change in Emotional Functioning Task Accuracy Emotion discrimination: Faces	87.1 percentage of correct responses Standard Error 2.4	92.3 percentage of correct responses Standard Error 1.8	93.2 percentage of correct responses Standard Error 1.7
Change in Emotional Functioning Task Accuracy Emotional conflict Stroop: Congruent	99.5 percentage of correct responses Standard Error 0.3	99.8 percentage of correct responses Standard Error 0.2	99.5 percentage of correct responses Standard Error 0.3
Change in Emotional Functioning Task Accuracy Emotional conflict Stroop: Incongruent	98.1 percentage of correct responses Standard Error 0.7	97.9 percentage of correct responses Standard Error 0.7	98.4 percentage of correct responses Standard Error 0.6
Change in Emotional Functioning Task Accuracy Emotion recognition task: Fearful	100.0 percentage of correct responses Standard Error 0.0	99.0 percentage of correct responses Standard Error 1.0	97.9 percentage of correct responses Standard Error 1.5
Change in Emotional Functioning Task Accuracy Emotion recognition task: Neutral	93.8 percentage of correct responses Standard Error 2.5	96.9 percentage of correct responses Standard Error 1.8	100.0 percentage of correct responses Standard Error 0.0

SECONDARY outcome

Timeframe: 1-day pre (baseline), 1-week post, 1-month post session

Outcome measures

Outcome measures
Measure	Baseline n=12 Participants One day prior to psilocybin administration.	1-week Post Session n=12 Participants One week post psilocybin (25 mg/70 kg) administration.	1-month Post Session n=12 Participants One month post psilocybin (25 mg/70 kg) administration.
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotion recognition task: Happy	1670 milliseconds Standard Error 59.5	1383 milliseconds Standard Error 41.2	1454 milliseconds Standard Error 45.6
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotion recognition task: Sad	1539 milliseconds Standard Error 53.0	1458 milliseconds Standard Error 45.6	1596 milliseconds Standard Error 56.8
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotion recognition task: Fearful	1061 milliseconds Standard Error 27.2	1045 milliseconds Standard Error 31.8	1130 milliseconds Standard Error 40.8
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotion recognition task: Angry	1380 milliseconds Standard Error 45.9	1193 milliseconds Standard Error 36.4	1310 milliseconds Standard Error 40.9
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotion recognition task: Neutral	1305 milliseconds Standard Error 49.1	1594 milliseconds Standard Error 49.2	1017 milliseconds Standard Error 33.4
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotion discrimination task: Faces	1803 milliseconds Standard Error 51.1	1572 milliseconds Standard Error 41.1	1522 milliseconds Standard Error 35.3
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotional conflict Stroop: Congruent	613.5 milliseconds Standard Error 6.32	606.3 milliseconds Standard Error 5.88	603.2 milliseconds Standard Error 7.18
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotional conflict Stroop: Incongruent	641.3 milliseconds Standard Error 7.14	631.4 milliseconds Standard Error 7.03	614.1 milliseconds Standard Error 6.71
Change in Emotional Functioning Tasks Response Time (Milliseconds) Emotion discrimination task: Shapes	977.0 milliseconds Standard Error 212.9	1697 milliseconds Standard Error 414.1	1735 milliseconds Standard Error 434.9

Adverse Events

Psilocybin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Psilocybin n=13 participants at risk Participants will be administered a 25 mg/70 kg dose of psilocybin Psilocybin: 25 mg/70 kg Psilocybin
Cardiac disorders Cardiac event	15.4% 2/13 • Number of events 2 • Adverse events were assessed from Screening to 1-month post psilocybin session (32-70 days).
Endocrine disorders Thyroid hormone changes	7.7% 1/13 • Number of events 1 • Adverse events were assessed from Screening to 1-month post psilocybin session (32-70 days).

Additional Information

Frederick Barrett, Ph.D., Principal Investigator

Johns Hopkins University School of Medicine

Phone: 4105509777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place