Psilocybin-assisted CBT for Depression

Status Enrolling by invitation

Clinical Trial Summary

The primary objectives of this clinical investigation are to (1) determine the feasibility of joining psilocybin treatment with CBT (cognitive-behavioral therapy) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) determine the initial efficacy of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. Psilocybin will be administered orally in two doses during the course of 12 sessions of CBT to eligible study participants - a 10mg dose following the third session and a 25mg dose following the sixth session. Participants will be in active treatment for the first 4 months (psilocybin + CBT) of the study and then followed for an additional 3-months following the termination of CBT.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05227612
Study type	Interventional
Source	University of California, Los Angeles
Contact
Status	Enrolling by invitation
Phase	Early Phase 1
Start date	June 27, 2023
Completion date	December 2025

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