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NCT05947383 · ClinicalTrials.gov registry record · Phase 2
Two Doses of Psilocybin for the Treatment of MDD in Adults With Cancer
A Phase 2 study of Cancer and Major Depressive Disorder, sponsored by Sunstone Medical.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT05947383: Recruiting Phase 2 study of Cancer and Major Depressive Disorder, sponsored by Sunstone Medical.
NCT05947383 is a Phase 2 study of Cancer and Major Depressive Disorder that is actively recruiting participants, run by Sunstone Medical. The registered enrollment target is 56 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05947383, a Phase 2 study of Cancer and Major Depressive Disorder, is actively recruiting participants, sponsored by Sunstone Medical.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and subsequently allow rollover into an open-label portion (Dosing Session 2; fixed dose of psilocybin, 25 mg) for patients who do not achieve remission of MDD symptoms after the first dose. In Dosing Session 1, groups of two to four patients will be randomized, as a cohort, to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session, with each patient supported by their dedicated study therapist and monitored by a second therapist via video feed. In Dosing Session 2, all eligible participants (i.e., patients who have not achieved remission defined as MADRS \< 10 at V7) will receive psilocybin 25 mg in an open-label fashion using the group session model. The study population will include adult men and women who are 18 years of age or older and have diagnoses of both MDD and a malignant neoplasm. MDD is defined as the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the International Classification of Diseases, 10th edition (ICD-10). Participants will be recruited through referrals from specialized psychiatric and oncology services as well as through patient self-referrals. The majority of participants will have no prior exposure to psilocybin or so-called "magic mushrooms"; however, participants with prior recreational experience with psilocybin or "magic mushrooms" are eligible.
Primary Outcome
The primary endpoint of efficacy (psilocybin versus active placebo) in this study will be evaluated as change from baseline in MADRS total score at V7 (Week 8).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Psilocybin
Study Locations (1)
Maryland
- Sunstone Medical, PC - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2023-10-23 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 2 |
What NCT05947383 shows while recruiting
NCT05947383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05947383 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05947383 about?
NCT05947383 is a clinical study titled "Two Doses of Psilocybin for the Treatment of MDD in Adults With Cancer". This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, rand...
What is the current status of trial NCT05947383?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2023-10-23. Estimated completion is 2026-03-01.
What conditions does trial NCT05947383 study?
This clinical trial studies the following conditions: Cancer, Major Depressive Disorder.
What interventions are being tested in trial NCT05947383?
The interventions under investigation include: Placebo (DRUG), Psilocybin (DRUG).
Who is sponsoring clinical trial NCT05947383?
This trial is sponsored by Sunstone Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05947383 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05947383's enrollment target sits among peer trials
56 412th of 615 higher than 202 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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