Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Psilocybin · 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...
Top 20 of 29 competitors
Psilocybin is an investigational small molecule being developed by COMPASS Pathways for several psychiatric conditions, including Post Traumatic Stress Disorder, Body Dysmorphic Disorders, Anorexia Nervosa, Major Depressive Disorder, and Treatment Resistant Depression. It is currently in Phase 2 clinical trials and is not yet approved by the FDA.
Psilocybin targets the HTR2A receptor, acting as an agonist. This means it binds to and activates the serotonin 2A receptor, which is thought to modulate mood and perception. This mechanism is being studied for its potential therapeutic effects in various psychiatric disorders.
Psilocybin is being developed by COMPASS Pathways Plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CMPS. The company is conducting clinical trials to evaluate the safety and efficacy of psilocybin for multiple psychiatric indications.
Psilocybin is currently in Phase 2 clinical development. It is being studied in multiple Phase 2 trials for conditions such as Post Traumatic Stress Disorder, Anorexia Nervosa, and Major Depressive Disorder. Psilocybin is an investigational drug and has not received FDA approval.
Psilocybin is being evaluated in several clinical trials, including NCT05312151 for Post Traumatic Stress Disorder, NCT05481736 for Anorexia Nervosa, and NCT05733546 for Major Depressive Disorder. These trials are Phase 2 studies with active or completed status, involving adult participants.
Psilocybin is the active ingredient in COMP360, which is the investigational drug product developed by COMPASS Pathways. Clinical trials such as NCT05312151 and NCT05733546 refer to COMP360, indicating that COMP360 contains psilocybin as its active pharmaceutical ingredient.