Psilocybin for Depression
(PACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
More efficacious treatments for Major Depressive Disorder (MDD) in Veterans are urgently needed. Psilocybin is a promising novel treatment that is likely to be the first FDA-approved psychedelic, but its safety and efficacy remain unclear. To address this gap, the investigators propose a randomized controlled trial of a single dose of psilocybin paired with a brief course of a VA-endorsed evidence-based psychotherapy (Acceptance and Commitment Therapy) in Veterans with MDD. Our trial addresses key limitations of previous studies including the challenge of management of expectancy effects, a focus on Veterans with input from Veterans, and a study population that reflects the demographics and medical and psychiatric complexity of the VHA patient population. Our study also explores psilocybin's antidepressant mechanisms focusing on changes in psychological flexibility and synaptic plasticity. In sum, this study will provide critical and timely data to determine if psilocybin treatment is a safe and efficacious treatment for MDD in Veterans.
Who Is on the Research Team?
Josh Woolley, BS PhD MD
Principal Investigator
San Francisco VA Medical Center, San Francisco, CA
Are You a Good Fit for This Trial?
This trial is for veterans diagnosed with major depressive disorder who are seeking new treatment options. Participants should be able to safely take psilocybin and engage in psychotherapy. Those with certain medical or psychiatric conditions that could make participation unsafe may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The study tests a single dose of psilocybin combined with brief Acceptance and Commitment Therapy, compared to other medications like modafinil, pimavanserin, or zolpidem. Participants are randomly assigned to different groups.
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
Participants will receive a single dose of 1-30mg of psilocybin, in addition to 2 other drugs: zolpidem, pimavanserin, and placebo. All participants will be masked to the probability of being assigned to a specific arm
Participants will receive a single dose of 1-30mg of psilocybin, in addition to 1 other drug: zolpidem, and placebo. All participants will be masked to the probability of being assigned to a specific arm
Participants will receive a single dose of 1-30mg of psilocybin, in addition to 1 other drug: pimavanserin, and placebo. All participants will be masked to the probability of being assigned to a specific arm
Participants will receive a single dose of 1-30mg of psilocybin, in addition to 3 other drugs: modafinil, zolpidem, pimavanserin. All participants will be masked to the probability of being assigned to a specific arm
Participants will receive a single dose of 1-30mg of psilocybin, in addition to 2 other drugs: modafinil and zolpidem and placebo. All participants will be masked to the probability of being assigned to a specific arm
Participants will receive a single dose of 1-30mg of psilocybin, in addition to 2 other drugs: modafinil, pimavanserin, and placebo. All participants will be masked to the probability of being assigned to a specific arm
Participants will receive a single dose of 1-30mg of psilocybin, in addition to 1 other drug: modafinil, and placebo. All participants will be masked to the probability of being assigned to a specific arm
Participants will receive a single dose of 1-30mg of psilocybin, and placebo. All participants will be masked to the probability of being assigned to a specific arm
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
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