Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Psilocybin
COMP360 · 10 trials · 5 indications
A transdiagnostic state measure of rumination over the previous two weeks consisting of 9 items on a 5 point Likert scale from 0 (Never/Rarely) to 4 (All The Time).
Changes in resting-state activity during functional magnetic resonance imaging(fMRI) scans.
Participants are shown words one at a time and asked to answer if each of the words apply to 'Self' or 'Other'.
Changes in activity in the default mode network during functional magnetic resonance imaging(fMRI) scans while participants perform a self-attribution task.
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
The C-SSRS will be used to assess suicide potential or tendency as a study entry criteria and monitored throughout the study.
The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item, semi-structured, rater-administered measure that assesses body dysmorphic disorder severity during the past week. Scores for each item range from 0 (no symptoms) to 4 (extreme symptoms); the total score ranges from 0 to 48, with higher scores reflecting more severe symptoms.
Proportion of patients with adverse events (AEs)
The EDE is a structured clinical interview (investigator rated) used to measure severity of the characteristic psychopathology of eating disorders
A TEAE is defined as an adverse event (AE) that has an onset on or after the dose of study drug, or any pre-existing AE condition that has worsened on or after the dose of study drug.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Psilocybin | EXPERIMENTAL | 25mg Psilocybin |
| 25 mg COMP360 Psilocybin | EXPERIMENTAL | 25 mg COMP360 Psilocybin |
| 10 mg COMP360 Psilocybin | EXPERIMENTAL | 10 mg COMP360 Psilocybin |
| 1 mg COMP360 Psilocybin | ACTIVE_COMPARATOR | 1 mg COMP360 Psilocybin, active comparator |
| Placebo | PLACEBO_COMPARATOR | Matched placebo |
| Safety, Tolerability, and Treatment | EXPERIMENTAL | On dosing day, each participant will receive 1 x 25 mg treatment bottle containing 5 x 5 mg oral capsules of psilocybin. The administration session will last approximately 4-6 hours and will be supported by a lead therapist and an assisting therapist. |
| COMP360 Psilocybin | EXPERIMENTAL | 25 mg COMP360 Psilocybin |
| Low dose | EXPERIMENTAL | Low dose Psilocybin |
| Medium dose | EXPERIMENTAL | Medium dose Psilocybin |
| High dose | EXPERIMENTAL | High dose Psilocybin |
| Name | Type | Description |
|---|---|---|
| Psilocybin | DRUG | COMP360 (Brand name of psilocybin to be used) |
Inclusion Criteria: 1. Must be able to sign the informed consent form (ICF). Participants will demonstrate capacity to provide informed consent by demonstrated understanding of the protocol and what their involvement in the study requires from them. 2. Be 18-55 years of age at screening. 3. At leas...
COMP360 is an investigational small molecule being developed by COMPASS Pathways Plc for psychiatric conditions. It is a synthetic form of psilocybin, also known simply as psilocybin, and is being studied in major depressive disorder, treatment resistant depression, anorexia nervosa, body dysmorphic disorder, and post traumatic stress disorder.
COMP360 is being studied for several psychiatric indications: major depressive disorder, treatment resistant depression, anorexia nervosa, body dysmorphic disorder, and post traumatic stress disorder. It is investigational and has not been approved for any use. Clinical work to date has focused mainly on depression, including a Phase 3 program in treatment resistant depression.
COMP360 is being developed by COMPASS Pathways Plc, which trades on the Nasdaq under the ticker CMPS as American Depositary Shares. The company sponsors the clinical program, including the Phase 2 and Phase 3 studies of COMP360 in major depressive disorder and treatment resistant depression.
COMP360 is in Phase 2 and Phase 3 clinical development, depending on the indication and study. It is investigational and has not been approved by the FDA or any other regulator. The program includes a completed Phase 3 trial in treatment resistant depression and a Phase 2 study in recurrent major depressive disorder.
COMP360 has been studied across four registered trials. These include NCT05624268, a completed Phase 3 trial in treatment resistant depression, and NCT05711940, an active Phase 3 trial of two administrations in treatment resistant depression. NCT05733546 is a Phase 2 study in recurrent major depressive disorder, and NCT06247839 is a recruiting Phase 3 study in major depressive disorder.
Yes, COMP360 is also known as psilocybin. COMP360 is the development name COMPASS Pathways uses for its synthetic psilocybin formulation, so searches for psilocybin in depression research often refer to this program. It is an investigational small molecule and is not an approved medicine.