Trial · NCT04739865
The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression
NCT04739865, Phase 2, Completed, COMPASS Pathways; results first posted 2023-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression. Trials, record NCT04739865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04739865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression
- NCT number
- NCT04739865
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- COMPASS Pathways
- Conditions
- Treatment Resistant Depression
- Interventions
- Psilocybin
- First posted
- 2021-02-05
- Last updated
- 2023-11-09
- Results first posted
- 2023-11-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in Depressive Symptoms | 3 weeks | 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. |
| Secondary | Incidence of Response | 3 weeks | 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. |
| Secondary | Incidence of Remission | 3 weeks | 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. |
| Secondary | Improvement in Clinical Global Impression - Severity | 3 weeks | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement in Depressive Symptoms | 3 weeks | Full analysis set - all participants who receive study drug and have at least 1 post-baseline efficacy assessment. | units on a scale | MEAN |
| SECONDARY | Incidence of Response | 3 weeks | Full analysis set - all participants who receive study drug and have at least 1 post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Remission | 3 weeks | Full analysis set - All participants who receive study drug and have at least 1 post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Improvement in Clinical Global Impression - Severity | 3 weeks | Full analysis set - All participants who receive study drug and have at least 1 post-baseline efficacy assessment. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improvement in Depressive Symptoms | 25 mg COMP360 Psilocybin | -14.9 | Standard Deviation 11.97 | units on a scale | |
| Incidence of Response | 25 mg COMP360 Psilocybin | 8 | Participants | ||
| Incidence of Remission | 25 mg COMP360 Psilocybin | 8 | Participants | ||
| Improvement in Clinical Global Impression - Severity | 25 mg COMP360 Psilocybin | -1.3 | Standard Deviation 1.29 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 25 mg COMP360 Psilocybin | 19 | |
| Overall Study | COMPLETED | 25 mg COMP360 Psilocybin | 19 | |
| Overall Study | NOT COMPLETED | 25 mg COMP360 Psilocybin | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | 25 mg COMP360 Psilocybin | 1 | 19 | 1 |
| other | Vertigo | Ear and labyrinth disorders | 25 mg COMP360 Psilocybin | 1 | 19 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | 25 mg COMP360 Psilocybin | 1 | 19 | 1 |
| other | Dry Mouth | Gastrointestinal disorders | 25 mg COMP360 Psilocybin | 1 | 19 | 1 |
| other | Fall | Injury, poisoning and procedural complications | 25 mg COMP360 Psilocybin | 1 | 19 | 1 |
| other | Skin Abrasion | Injury, poisoning and procedural complications | 25 mg COMP360 Psilocybin | 1 | 19 | 1 |
| other | Blood Pressure Increased | Investigations | 25 mg COMP360 Psilocybin | 3 | 19 | 3 |
| other | Headache | Nervous system disorders | 25 mg COMP360 Psilocybin | 6 | 19 | 6 |
| other | Dizziness | Nervous system disorders | 25 mg COMP360 Psilocybin | 1 | 19 | 1 |
| other | Depression | Psychiatric disorders | 25 mg COMP360 Psilocybin | 1 | 19 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 25 mg COMP360 Psilocybin | 0 | 19 |
| Total, other adverse events | 25 mg COMP360 Psilocybin | 12 | 19 |
| Total, serious adverse events | 25 mg COMP360 Psilocybin | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04739865
GET https://conductscience.org/api/trials/v1/NCT04739865/registered