Psilocybin + Cognitive Behavioral Therapy for Depression

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Must be taking: Anti-hypertensives

Must not be taking: Antidepressants, Opioids, Lithium, others

Disqualifiers: Psychosis, Hypertension, Personality disorders, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 21 and 60 years old.

* 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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 sessions of PA-CBT and two administrations of psilocybin in a group format

4 months

12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

How Is the Trial Designed?

Group I: Group PACBT Experimental Treatment 2 Interventions

12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023) and two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later), all of which will be delivered in a group format whereby participants receive the treatments together and simultaneously

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+