Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Psilocybin · 1 trial · 1 indication
Participant drop-out rates will be calculated to determine the feasibility of psilocybin in adults with treatment-resistant depression.
Feasibility will be judged based on change in Columbia Suicide Severity Rating Scale (CSSRS) scores. The CSSRS evaluates suicidal ideation and behaviour. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Feasibility will be judged based on the percentage of participants experiencing serious adverse events and the percentage of adverse events resolving within 48 hours of each dose administration.
| Arm | Type | Description |
|---|---|---|
| Immediate treatment | EXPERIMENTAL | Participants will commence psilocybin treatment immediately upon study enrollment. |
| Delayed treatment | EXPERIMENTAL | Participants will commence psilocybin treatment two weeks after study enrollment. |
| Name | Type | Description |
|---|---|---|
| Psilocybin | DRUG | Participants will receive a single dose of psilocybin and be assessed weekly for six weeks and biweekly for 18 weeks. Participants who relapse may receive up to two repeated doses of psilocybin. |
Inclusion Criteria: 1. Over the age of 18 years and under the age of 65; 2. Diagnosed with major depressive disorder or bipolar II disorder by a healthcare provider; 3. Experiencing a major depressive episode (MDE) without psychotic features as defined and operationalized in the DSM-5, where the du...
Psilocybin is an investigational small molecule being studied for the treatment of Treatment Resistant Depression. It is in Phase 2 clinical development and is being developed by Cognition Therapeutics, Inc. (CGTX). The drug is intended for patients who have not responded to standard depression treatments.
Psilocybin is being developed by Cognition Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker CGTX. The company is conducting clinical research to evaluate the drug's potential in treating Treatment Resistant Depression.
Psilocybin is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with Treatment Resistant Depression.
Psilocybin has one completed Phase 2 clinical trial, identified as NCT05029466, titled "Psilocybin for Treatment-Resistant Depression." The trial enrolled 30 participants in Canada, with a minimum age of 18 years, and included both male and female participants. The study was controlled and randomized.
Psilocybin is a distinct investigational compound being studied specifically for Treatment Resistant Depression. It is a small molecule and is not the same as other marketed depression medications. Its development is focused on patients who have not achieved adequate response to existing therapies.