Trials / Unknown
UnknownNCT04959253
Psilocybin in Depression Resistant to Standard Treatments
A Randomised, Placebo Controlled Trial of Psilocybin in Treatment Resistant Depression: A Feasibility Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- King's College London · Academic / Other
- Sex
- All
- Age
- 25 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A single centre clinical trial to evaluate the feasibility, safety and efficacy of psilocybin, given under supportive conditions, in a randomised, blinded design in adult participants with treatment resistant major depressive disorder. The primary objective is to evaluate feasibility by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Psilocybin assisted therapy | A package of psychological therapy and a single dosing session of psilocybin. |
| COMBINATION_PRODUCT | Placebo assisted therapy | A package of psychological therapy and a single dosing session of placebo. |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2023-09-01
- Completion
- 2023-11-01
- First posted
- 2021-07-13
- Last updated
- 2021-07-22
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04959253. Inclusion in this directory is not an endorsement.