Trial Outcomes & Findings for Psilocybin-assisted CBT for Depression (NCT NCT05227612)
NCT ID: NCT05227612
Last Updated: 2026-05-19
Results Overview
Participant feedback related to the treatment on the Client Satisfaction Questionnaire-8. Scores can range from 8-32 with higher scores indicating greater satisfaction.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
4-month treatment period
Results posted on
2026-05-19
Participant Flow
Participant milestones
| Measure |
Psilocybin-assisted Cognitive Behavioral Therapy (PACBT)
Two psilocybin sessions (10mg and 25mg) and 12 sessions of psychotherapy (preparation + CBT)
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psilocybin-assisted CBT for Depression
Baseline characteristics by cohort
| Measure |
Psilocybin-assisted Cognitive Behavioral Therapy (PACBT)
n=16 Participants
Two psilocybin sessions (10mg and 25mg) and 12 sessions of psychotherapy (preparation + CBT)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 4-month treatment periodParticipant feedback related to the treatment on the Client Satisfaction Questionnaire-8. Scores can range from 8-32 with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Psilocybin-assisted Cognitive Behavioral Therapy (PACBT)
n=16 Participants
Two psilocybin sessions (10mg and 25mg) and 12 sessions of psychotherapy (preparation + CBT)
|
|---|---|
|
Treatment Acceptability (Client Satisfaction Questionnaire-8)
|
30.8 scores on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 4-month treatment periodRetention of participants in the trial
Outcome measures
| Measure |
Psilocybin-assisted Cognitive Behavioral Therapy (PACBT)
n=16 Participants
Two psilocybin sessions (10mg and 25mg) and 12 sessions of psychotherapy (preparation + CBT)
|
|---|---|
|
Study Feasibility (Number of Participants That Completed the 4-month Treatment)
|
16 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-treatment (an average of 4 months), and 3-month follow-up (an average of 7-months)Symptom severity scored from 0-53, with larger values indicating greater depressive severity, as measured repeatedly at the baseline assessment
Outcome measures
| Measure |
Psilocybin-assisted Cognitive Behavioral Therapy (PACBT)
n=16 Participants
Two psilocybin sessions (10mg and 25mg) and 12 sessions of psychotherapy (preparation + CBT)
|
|---|---|
|
Hamilton Depression Rating Scale (HAM-D)
Baseline
|
20.2 scores on a scale
Standard Error 1.0
|
|
Hamilton Depression Rating Scale (HAM-D)
Post-treatment
|
9.9 scores on a scale
Standard Error 2.1
|
|
Hamilton Depression Rating Scale (HAM-D)
3-month follow-up
|
9.6 scores on a scale
Standard Error 2.0
|
PRIMARY outcome
Timeframe: Baseline, Post-treatment (an average of 4 months), and 3-month follow-up (an average of 7-months)psychosocial functioning scored from 0-100, with larger values indicating better functioning
Outcome measures
| Measure |
Psilocybin-assisted Cognitive Behavioral Therapy (PACBT)
n=16 Participants
Two psilocybin sessions (10mg and 25mg) and 12 sessions of psychotherapy (preparation + CBT)
|
|---|---|
|
Global Assessment of Functioning (GAF)
Baseline
|
56.1 scores on a scale
Standard Error 3.0
|
|
Global Assessment of Functioning (GAF)
Post-treatment
|
67.6 scores on a scale
Standard Error 3.0
|
|
Global Assessment of Functioning (GAF)
3-month follow-up
|
65.9 scores on a scale
Standard Error 2.7
|
Adverse Events
Psilocybin-assisted Cognitive Behavioral Therapy (PACBT)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Psilocybin-assisted Cognitive Behavioral Therapy (PACBT)
n=16 participants at risk
Two psilocybin sessions (10mg and 25mg) and 12 sessions of psychotherapy (preparation + CBT)
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle tension
|
12.5%
2/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Cardiac disorders
Orthostatic presyncope
|
6.2%
1/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Ear and labyrinth disorders
Congestion
|
6.2%
1/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Eye disorders
Blurred vision
|
12.5%
2/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Gastrointestinal disorders
Gastrointestinal upset
|
25.0%
4/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
General disorders
Dry mouth
|
12.5%
2/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Nervous system disorders
Headache
|
81.2%
13/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Nervous system disorders
Fatigue
|
18.8%
3/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Nervous system disorders
Clammy hands
|
6.2%
1/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Psychiatric disorders
Transiet anxiety
|
12.5%
2/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Psychiatric disorders
Reduced sleep
|
6.2%
1/16 • From enrollment until end of follow-up (i.e., 7 months)
|
|
Psychiatric disorders
Suicidal ideation
|
6.2%
1/16 • From enrollment until end of follow-up (i.e., 7 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place