62 Participants Needed

Psilocybin-assisted CBT for Depression

AS
SG
Overseen ByShelby Grody
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of California, Los Angeles
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. This study has two phases. Phase I will involve an open trial of PA-CBT where participants will receive two doses of psilocybin (10mg and then 25mg, separated by one month) plus 12 sessions of cognitive behavioral therapy. Phase II will be a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to PA-CBT. Both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). In Phase II, participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).

Will I have to stop taking my current medications?

Yes, you will need to stop taking antidepressants or other medications that affect serotonin, like St. John's Wort, to participate in this trial.

What data supports the effectiveness of the drug psilocybin for depression?

Research shows that psilocybin can quickly reduce symptoms of depression, with effects lasting long after just one or two doses. It has been well-tolerated in clinical trials, even helping some patients who didn't respond to other treatments.12345

Is psilocybin generally safe for human use?

Psilocybin has been studied in healthy adults with escalating doses, showing a safety profile that supports its use under controlled conditions. However, caution is advised, especially for individuals with cardiovascular issues, as its safety in such conditions is not fully known.46789

How is psilocybin-assisted CBT for depression different from other treatments?

Psilocybin-assisted CBT for depression is unique because it combines the psychedelic effects of psilocybin, which can rapidly reduce depression symptoms, with cognitive behavioral therapy (CBT), a structured talk therapy. This combination aims to enhance the therapeutic process by potentially opening new perspectives and emotional insights during therapy sessions.19101112

Eligibility Criteria

This trial is for adults aged 21-60 with depression, who are experiencing a major depressive episode. They must be able to swallow capsules and have someone to drive them home after sessions. Women should use effective contraception. Exclusions include active suicidality, current antidepressant use, certain cardiovascular conditions, insulin-dependent diabetes, history of psychosis or bipolar in the family, prior adverse reaction to psychedelics, pregnancy or nursing.

Inclusion Criteria

Patient has been medically cleared for the study by a physician
For women of child-bearing potential - using one form of highly effective contraception and willingness to continue contraceptive use for duration of study
I have been diagnosed with major depression now or in the past.
See 4 more

Exclusion Criteria

I am currently undergoing cognitive behavioral therapy.
Adverse prior reaction to a psychedelic agent
I have a heart condition.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Open trial of PA-CBT with two doses of psilocybin (10mg and 25mg) and 12 sessions of cognitive behavioral therapy

4 months
12 therapy sessions

Phase II Treatment

Randomized trial with two arms: 12-session PA-CBT or 6-session standard psilocybin-assisted therapy, both with two doses of psilocybin

4 months
6-12 therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

  • Psilocybin
Trial OverviewThe study tests combining psilocybin (a psychedelic drug) with cognitive-behavioral therapy (CBT) for treating major depressive disorder. Participants will receive two oral doses of psilocybin during twelve CBT sessions over four months and then be followed up for three additional months.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Psilocybin + CBTExperimental Treatment2 Interventions
Participants will receive 12 sessions of cognitive-behavioral therapy (CBT) along with two psilocybin-drug sessions -- the first following the third CBT session (10mg of psilocybin, taken orally) and the second following the sixth CBT session (25mg of psilocybin, taken orally).
Group II: Psilocybin + Minimal supportive therapyActive Control2 Interventions
Participants will receive 6 sessions of supportive, non-directive therapy along with two psilocybin-drug sessions -- the first following the third therapy session (10mg of psilocybin, taken orally) and the second following the fourth therapy session (25mg of psilocybin, taken orally).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Findings from Research

Psilocybin has shown promise in clinical trials for reducing symptoms of depression, indicating its potential as a novel treatment option.
Patients with treatment-resistant depression (TRD) may benefit the most from psilocybin therapy, although the risks associated with its use are still not fully understood.
Assessing potential of psilocybin for depressive disorders.Kozak, Z., Johnson, MW., Aaronson, ST.[2023]
Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.
The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.
[Treatment with psilocybin: applications for patients with psychiatric disorders].Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]
In a placebo-controlled study involving individuals with moderate to severe major depressive disorder, psilocybin (0.3 mg/kg) showed larger antidepressant effect sizes compared to placebo, with 66.7% of participants responding and 46.7% achieving remission after treatment.
The antidepressant effects of psilocybin persisted for an average of 2 months, indicating its potential as a long-lasting treatment option for depression, although the strength of the mystical experience during dosing did not correlate with these effects.
Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial.Sloshower, J., Skosnik, PD., Safi-Aghdam, H., et al.[2023]

References

Assessing potential of psilocybin for depressive disorders. [2023]
[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. [2023]
The pharmacology of psilocybin. [2016]
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]
[Hallucinogenic mushrooms]. [2018]
Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. [2021]
Intravenous mushroom poisoning. [2019]
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]
Psilocybin-assisted therapy for depression: A systematic review and dose-response meta-analysis of human studies. [2023]
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. [2023]
Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. [2020]