Group PACBT for Depression (NCT07566104) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Group PACBT for Depression
United States30 participantsStarted 2027-01
Plain-language summary
This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.
Who can participate
Age range21 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 21-60,
* Fluent in English
* Able to swallow capsules,
* Meets for a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),
* Active current depressive symptoms (i.e., scores \>16 on the Hamilton-Depression Rating Scale covering the prior 2 weeks; Hamilton, 1986),
* Have an identified support person (i.e., trusted adult friend or relative) who can pick up the individual from UCLA Semel Institute and drive individual home following psilocybin sessions,
* For women of child-bearing potential - using one form of highly effective contraception (e.g., oral contraceptive pill) and willingness to continue contraceptive use for duration of study. Must be willing to take on-site pregnancy tests.
* Agree to refrain from any psychoactive drug (including alcohol) within 24 hours of each drug session and during the drug sessions. Participants will be allowed to consume their usual amount of caffeine prior to and after the drug sessions.
* Agree to not take any PRN medications on the mornings of the drug sessions
* Has been medically cleared for the study by a physician
* Participants must remain on anti-hypertensive medications if prescribed previously to manage hypertension
Exclusion Criteria:
* A personal or family history (first-degree) of psychosis or mania
* Resting blood pressure above 140 systolic, 90 diastolic or heart rate \> 90 beats per minute (averaged across…