Trial Outcomes & Findings for The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression (NCT NCT04739865)

Last Updated: 2023-11-09

Results Overview

Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to 3 weeks post psilocybin administration. The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

3 weeks

Results posted on

2023-11-09

Participant Flow

First patient first visit: 10 August 2020 Last patient last visit: 13 October 2021

Participant milestones

Participant milestones
Measure	25 mg COMP360 Psilocybin 25 mg COMP360 Psilocybin
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psilocybin n=19 Participants 25mg Psilocybin Psilocybin: Open label
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.2 years STANDARD_DEVIATION 10.80 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Region of Enrollment Ireland	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: Full analysis set - all participants who receive study drug and have at least 1 post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	25 mg COMP360 Psilocybin n=19 Participants 25 mg COMP360 Psilocybin Psilocybin: Open label
Improvement in Depressive Symptoms	-14.9 units on a scale Standard Deviation 11.97

SECONDARY outcome

Timeframe: 3 weeks

Population: Full analysis set - all participants who receive study drug and have at least 1 post-baseline efficacy assessment.

The proportion of participants with a response (defined as a ≥ 50% improvement in Montgomery-Asberg Depression Rating Scale \[MADRS\] total score from Baseline) at Week 3 post psilocybin administration. The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	25 mg COMP360 Psilocybin n=19 Participants 25 mg COMP360 Psilocybin Psilocybin: Open label
Incidence of Response	8 Participants

SECONDARY outcome

Timeframe: 3 weeks

Population: Full analysis set - All participants who receive study drug and have at least 1 post-baseline efficacy assessment.

The proportion of participants with remission (defined as Montgomery-Asberg Depression Rating Scale \[MADRS\] total score ≤ 10) at Week 3 post psilocybin administration The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	25 mg COMP360 Psilocybin n=19 Participants 25 mg COMP360 Psilocybin Psilocybin: Open label
Incidence of Remission	8 Participants

SECONDARY outcome

Timeframe: 3 weeks

Population: Full analysis set - All participants who receive study drug and have at least 1 post-baseline efficacy assessment.

Changes from Baseline in Clinical Global Impression-Severity score at Week 3 post psilocybin administration. The minimum and maximum values are 1 and 7 and a higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	25 mg COMP360 Psilocybin n=19 Participants 25 mg COMP360 Psilocybin Psilocybin: Open label
Improvement in Clinical Global Impression - Severity	-1.3 units on a scale Standard Deviation 1.29

Adverse Events

25 mg COMP360 Psilocybin

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	25 mg COMP360 Psilocybin n=19 participants at risk 25 mg COMP360 Psilocybin Psilocybin: Open label
Cardiac disorders Palpitations	5.3% 1/19 • Number of events 1 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Ear and labyrinth disorders Vertigo	5.3% 1/19 • Number of events 1 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Gastrointestinal disorders Diarrhoea	5.3% 1/19 • Number of events 1 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Gastrointestinal disorders Dry Mouth	5.3% 1/19 • Number of events 1 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Injury, poisoning and procedural complications Fall	5.3% 1/19 • Number of events 1 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Injury, poisoning and procedural complications Skin Abrasion	5.3% 1/19 • Number of events 1 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Investigations Blood Pressure Increased	15.8% 3/19 • Number of events 3 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Nervous system disorders Headache	31.6% 6/19 • Number of events 6 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 1 • Up to 3 weeks Safety analysis set - All participants who receive study drug.
Psychiatric disorders Depression	5.3% 1/19 • Number of events 1 • Up to 3 weeks Safety analysis set - All participants who receive study drug.

Additional Information

Chief Medical Officer

COMPASS Pathways

Phone: 07443136539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60