Approval Probability
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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...
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COMP360 is an investigational psilocybin-based small molecule therapy being developed by COMPASS Pathways Plc for psychiatric conditions. It is being studied in major depressive disorder, treatment resistant depression, anorexia nervosa, body dysmorphic disorder, and post traumatic stress disorder. It has received FDA Breakthrough Therapy designation.
COMP360 is being developed to treat several psychiatric conditions, including treatment resistant depression, major depressive disorder, anorexia nervosa, body dysmorphic disorder, and post traumatic stress disorder. It is investigational and has not been approved for any indication. Its most advanced programs are in treatment resistant depression and major depressive disorder.
COMP360 is developed by COMPASS Pathways Plc, which trades on the Nasdaq under the ticker CMPS as American Depositary Shares. The company is the sponsor of the clinical trials evaluating COMP360 across its psychiatric indications.
COMP360 is in Phase 2 and Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes a completed Phase 3 trial and an active Phase 3 trial in treatment resistant depression, plus Phase 2 and Phase 3 studies in major depressive disorder.
COMP360 has been studied in four trials. NCT05624268, a completed Phase 3 trial in treatment resistant depression, enrolled 258 participants. NCT05711940, an active Phase 3 trial in treatment resistant depression, enrolled 572 across multiple countries. NCT05733546 is a Phase 2 trial in recurrent major depressive disorder, and NCT06247839 is a recruiting Phase 3 trial in major depressive disorder.
COMP360 is a psilocybin-based therapy, and psilocybin is the alternative name used for it. COMP360 refers specifically to the proprietary formulation developed by COMPASS Pathways Plc, distinguishing it from psilocybin in general use.