CAPSI - Cancer related major depression treated with a single dose of psilocybin - a multicenter randomized placebo controlled double blind clinical trial

Conditions

Major Depressive Disorder, Malignant tumours ICD 10 C00 to C97

Brief summary

The primary endpoint for the acute-phase (Day 0 to Day 42) is the endpoint score on the observer-rated MADRS total score. This will be assessed using ANCOVA. The primary endpoint for the follow-up phase (Day 43 to Day 180) is days to initiation of antidepressant treatment (antidepressants or psychotherapy) or hospitalization for depression from Day 43 to the date when either of the events has occurred.

Detailed description

MADRS at day 8 (ANCOVA x1) MADRS-S at all evaluations between Day 0 and Day 42 (MMRM x1) SDS, GAD-7 and HADS at Day 42 (ANCOVA x3) CGI, EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6) AQOL-6D at Day 42 (ANCOVA x1). MADRS at Day 90 and Day 180 (ANCOVA x2) MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1) SDS, GAD-7, HADS at Day 180 (ANCOVA x3) CGI, EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6) AQOL-6D at Day 90 and Day 180 (ANCOVA x2)

Morel NS, Stenbaek DS, Lundberg J, Beckman M.

2026-04-09

10.1186/s12909-026-09124-8

Interventions

DRUGUCB-J

DRUGPEX010 Psilocybin Capsules (1.0 mg psilocybin)

DRUGPEX010 (Psilocybin Capsules 25 mg)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint for the acute-phase (Day 0 to Day 42) is the endpoint score on the observer-rated MADRS total score. This will be assessed using ANCOVA. The primary endpoint for the follow-up phase (Day 43 to Day 180) is days to initiation of antidepressant treatment (antidepressants or psychotherapy) or hospitalization for depression from Day 43 to the date when either of the events has occurred.	—

Measure

Time frame

The primary endpoint for the acute-phase (Day 0 to Day 42) is the endpoint score on the observer-rated MADRS total score. This will be assessed using ANCOVA. The primary endpoint for the follow-up phase (Day 43 to Day 180) is days to initiation of antidepressant treatment (antidepressants or psychotherapy) or hospitalization for depression from Day 43 to the date when either of the events has occurred.

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Secondary

Measure	Time frame
MADRS at day 8 (ANCOVA x1) MADRS-S at all evaluations between Day 0 and Day 42 (MMRM x1) SDS, GAD-7 and HADS at Day 42 (ANCOVA x3) CGI, EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6) AQOL-6D at Day 42 (ANCOVA x1). MADRS at Day 90 and Day 180 (ANCOVA x2) MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1) SDS, GAD-7, HADS at Day 180 (ANCOVA x3) CGI, EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6) AQOL-6D at Day 90 and Day 180 (ANCOVA x2)	—