Trial Outcomes & Findings for The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression (NCT NCT03775200)

Last Updated: 2023-04-24

Results Overview

MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

233 participants

Primary outcome timeframe

Change from Baseline to Week 3

Results posted on

2023-04-24

Participant Flow

First patient first visit: 1 March 2019 Last patients last visit: 27 September 2021

Participant milestones

Participant milestones
Measure	25 mg COMP360 Psilocybin 25 mg COMP360 Psilocybin	10 mg COMP360 Psilocybin 10 mg COMP360 Psilocybin	1 mg COMP360 Psilocybin 1 mg COMP360 Psilocybin
Overall Study STARTED	79	75	79
Overall Study COMPLETED	74	66	69
Overall Study NOT COMPLETED	5	9	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	25 mg COMP360 Psilocybin n=79 Participants 25 mg COMP360 Psilocybin	10 mg COMP360 Psilocybin n=75 Participants 10 mg COMP360 Psilocybin	1 mg COMP360 Psilocybin n=79 Participants 1 mg COMP360 Psilocybin	Total n=233 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	73 Participants n=7 Participants	77 Participants n=5 Participants	226 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Age, Continuous	40.2 years STANDARD_DEVIATION 12.19 • n=5 Participants	40.6 years STANDARD_DEVIATION 12.76 • n=7 Participants	38.7 years STANDARD_DEVIATION 11.71 • n=5 Participants	39.8 years STANDARD_DEVIATION 12.19 • n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	34 Participants n=7 Participants	43 Participants n=5 Participants	112 Participants n=4 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	41 Participants n=7 Participants	36 Participants n=5 Participants	121 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants	72 Participants n=7 Participants	73 Participants n=5 Participants	215 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Canada	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment Netherlands	17 participants n=5 Participants	16 participants n=7 Participants	17 participants n=5 Participants	50 participants n=4 Participants
Region of Enrollment United States	32 participants n=5 Participants	32 participants n=7 Participants	32 participants n=5 Participants	96 participants n=4 Participants
Region of Enrollment Czechia	3 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants
Region of Enrollment Ireland	3 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	11 participants n=4 Participants
Region of Enrollment Denmark	3 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants	10 participants n=7 Participants	12 participants n=5 Participants	33 participants n=4 Participants
Region of Enrollment Portugal	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment Germany	2 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Spain	5 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	16 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from Baseline to Week 3

Population: The full analysis set includes all participants randomised who receive study drug and have at least 1 post-dose efficacy assessment.

Outcome measures

Outcome measures
Measure	25 mg COMP360 Psilocybin n=79 Participants 25 mg COMP360 Psilocybin	10 mg COMP360 Psilocybin n=75 Participants 10 mg COMP360 Psilocybin	1 mg COMP360 Psilocybin n=79 Participants 1 mg COMP360 Psilocybin
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3	-12 units on a scale Standard Deviation 12.98	-8.9 units on a scale Standard Deviation 10.94	-6.8 units on a scale Standard Deviation 11.10

PRIMARY outcome

Timeframe: Change from Baseline to Week 3

Population: The per-protocol analysis set includes all participants in the Full Analysis Set who do not have a protocol deviation that is thought to significantly affect the integrity of the participant's efficacy data.

Outcome measures

Outcome measures
Measure	25 mg COMP360 Psilocybin n=77 Participants 25 mg COMP360 Psilocybin	10 mg COMP360 Psilocybin n=65 Participants 10 mg COMP360 Psilocybin	1 mg COMP360 Psilocybin n=68 Participants 1 mg COMP360 Psilocybin
MADRS Change From Baseline to Week 3, Sensitivity Analysis	-12 units on a scale Standard Deviation 12.98	-8.9 units on a scale Standard Deviation 11.11	-6.7 units on a scale Standard Deviation 11.18

Adverse Events

25 mg COMP360 Psilocybin

Serious events: 5 serious events

Other events: 60 other events

Deaths: 0 deaths

10 mg COMP360 Psilocybin

Serious events: 6 serious events

Other events: 51 other events

Deaths: 0 deaths

1 mg COMP360 Psilocybin

Serious events: 1 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	25 mg COMP360 Psilocybin n=79 participants at risk 25 mg COMP360 Psilocybin	10 mg COMP360 Psilocybin n=75 participants at risk 10 mg COMP360 Psilocybin	1 mg COMP360 Psilocybin n=79 participants at risk 1 mg COMP360 Psilocybin
General disorders Drug withdrawal syndrome	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/75 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Suicidal behaviour	3.8% 3/79 • Number of events 3 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/75 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Intentional self-injury	2.5% 2/79 • Number of events 2 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	2.7% 2/75 • Number of events 2 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/79 • Number of events 2 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Adjustment disorder with anxiety	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/75 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Adjustment disorder with mixed anxiety and depressed mood	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/75 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Depression	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/75 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Suicidal ideation	2.5% 2/79 • Number of events 2 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	2.7% 2/75 • Number of events 3 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Surgical and medical procedures Hospitalisation	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/75 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.

Other adverse events

Additional Information

Medical Director

Compass Pathways

Phone: 07443136539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	25 mg COMP360 Psilocybin n=79 participants at risk 25 mg COMP360 Psilocybin	10 mg COMP360 Psilocybin n=75 participants at risk 10 mg COMP360 Psilocybin	1 mg COMP360 Psilocybin n=79 participants at risk 1 mg COMP360 Psilocybin
Gastrointestinal disorders Nausea	22.8% 18/79 • Number of events 19 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	9.3% 7/75 • Number of events 7 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	5.1% 4/79 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Gastrointestinal disorders Abdominal pain upper	5.1% 4/79 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	2.7% 2/75 • Number of events 2 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
General disorders Fatigue	15.2% 12/79 • Number of events 12 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	6.7% 5/75 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	8.9% 7/79 • Number of events 8 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Musculoskeletal and connective tissue disorders Back pain	7.6% 6/79 • Number of events 6 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/75 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	3.8% 3/79 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Musculoskeletal and connective tissue disorders Myalgia	6.3% 5/79 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	2.7% 2/75 • Number of events 2 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Nervous system disorders Headache	34.2% 27/79 • Number of events 34 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	21.3% 16/75 • Number of events 22 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	25.3% 20/79 • Number of events 30 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Nervous system disorders Dizziness	7.6% 6/79 • Number of events 6 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/75 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Nervous system disorders Paraesthesia	3.8% 3/79 • Number of events 3 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	5.3% 4/75 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Insomnia	10.1% 8/79 • Number of events 8 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	14.7% 11/75 • Number of events 11 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	17.7% 14/79 • Number of events 16 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Anxiety	8.9% 7/79 • Number of events 7 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	17.3% 13/75 • Number of events 16 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	3.8% 3/79 • Number of events 3 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Depression	5.1% 4/79 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	6.7% 5/75 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	6.3% 5/79 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Euphoric mood	5.1% 4/79 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	6.7% 5/75 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	5.1% 4/79 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Depressed mood	3.8% 3/79 • Number of events 3 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	6.7% 5/75 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	5.1% 4/79 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Suicidal ideation	6.3% 5/79 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	4.0% 3/75 • Number of events 3 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	5.1% 4/79 • Number of events 5 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Mood altered	8.9% 7/79 • Number of events 8 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	4.0% 3/75 • Number of events 3 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Irritability	5.1% 4/79 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	2.7% 2/75 • Number of events 2 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Panic reaction	5.1% 4/79 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/75 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	1.3% 1/79 • Number of events 1 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.
Psychiatric disorders Thinking abnormal	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	5.3% 4/75 • Number of events 4 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.	0.00% 0/79 • Up to 12 Weeks The Safety Analysis Set included all randomised participants who received study drug.