Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319378
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-11-08
Brief Title:
Cancer Related Major Depression Treated With a Single Dose of Psilocybin
Sponsor:
Section for Affective Disorders Northern Stockholm Psychiatry
Organization:
Section for Affective Disorders Northern Stockholm Psychiatry
Study Overview
Official Title:
CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPSI
Brief Summary:
The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder The main question it aims to answer is
The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder MDD compared to an active placebo psilocybin 1 mg assessed as the difference between groups in changes in depressive symptoms in the following Population 20-80 inclusive years old current depressive episode according to Patient Health Questionnaire PHQ-9
10 1 month after cancer diagnosis with at least 12 months of life expectancy willingness to abstain from other psychotherapeutic or antidepressant treatments during the study wash out time 5 half-lives
The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder MDD compared to an active placebo psilocybin 1 mg assessed as the difference between groups in changes in depressive symptoms in the following Population 20-80 inclusive years old current depressive episode according to Patient Health Questionnaire PHQ-9
10 1 month after cancer diagnosis with at least 12 months of life expectancy willingness to abstain from other psychotherapeutic or antidepressant treatments during the study wash out time 5 half-lives
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505532-35-00 | OTHER | CTIS | None |