Cancer Related Major Depression Treated With a Single Dose of Psilocybin
- Registration Number
- NCT06319378
- Lead Sponsor
- Section for Affective Disorders; Northern Stockholm Psychiatry
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description psilocybin 25 mg (active) psilocybin 25 mg sod - psilocybin 1 mg psilocybin 1 mg sod -
- Primary Outcome Measures
Name Time Method MADRS at day 42 day 42 Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)
- Secondary Outcome Measures
Name Time Method GAD-7 at Day 42 Day 42 General Anxiety Disorder 7 (GAD-7) (0-21, lower equals better)
MADRS day 8 day 8 Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)
MADRS-S at all evaluations between Day 0 and Day 42 (Mixed Models for Repeated Measures (MMRM) x1) Day 42 Montgomery Asberg Depression Rating Scale self rating (MADRS-S) (0-54, smaller equals better)
SDS at Day 180 (ANCOVA x3) Day 180 Sheehan Disability Scale (SDS) (0-10, smaller equals better)
EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6) Day 90 and Day 180 Euroqol 5 Dimension scale (EQ5D-5L), 0-1, higher equals better
AQOL-6D at Day 90 and Day 180 (ANCOVA x2) Day 90 and Day 180 Assessing Quality of Life 6 dimensions (AQOL-6D) (0-99, smaller equals better)
HADS at Day 42 Day 42 Hospital Anxiety and Depression Scale (HADS) (0-42, smaller equals better)
SDS at Day 42 Day 42 Sheehan Disability Scale (SDS) (0-10, smaller equals better)
AQOL-6D at Day 42 (ANCOVA x1) Day 42 Assessing Quality of Life 6 dimensions (AQOL-6D) (0-99, smaller equals better)
CGI at Day 90 and Day 180 (ANCOVA x6) Day 90 and Day 180 Clinical Global Impression (CGI), (1-7, smaller equals better)
CGI at Day 8 and Day 42 (analysis of covariance (ANCOVA) x6) Day 8 and 42 Clinical Global Impression (CGI), (1-7, smaller equals better)
MADRS at Day 90 and Day 180 (ANCOVA x2) Day 90 and Day 180 Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)
MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1) between Day 43 and Day 180 Montgomery Asberg Depression Rating Scale self rating (MADRS-S) (0-54, smaller equals better)
GAD-7 at Day 180 (ANCOVA x3) Day 180 General Anxiety Disorder 7 (GAD-7) (0-21, lower equals better)
EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6) Day 8 and 42 Euroquol 5 Dimension scale (EQ5D-5L), 0-1, higher equals better
HADS at Day 180 (ANCOVA x3) Day 180 Hospital Anxiety and Depression Scale (HADS) (0-42, smaller equals better)
Trial Locations
- Locations (4)
Norra Stockholms Psykiatri
🇸🇪Stockholm, Sweden
Psykiatriska Kliniken, Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
region Västra Götaland
🇸🇪Göteborg, Sweden
Örebro sjukhus
🇸🇪Örebro, Sweden