VA Office of Research and Development
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.
Major depressive disorder (MDD) affects 1 in 8 Veterans, leading to functional impairment, increased mortality, and high suicide risk. Veterans face complex psychiatric and medical comorbidities that often render conventional treatments inadequate, creating critical gaps in their mental health care. Psilocybin has emerged as a promising candidate treatment for MDD, but its safety and efficacy remain unclear. To address this gap, the investigators propose a four-site randomized clinical trial (RCT; N=120) to evaluate psilocybin-assisted Acceptance and Commitment Therapy (PACT) specifically for…
Inclusion Criteria: * Veteran * Depression determined by the Structured Clinical Interview for DSM-5 (SCID) collected at screening visit * Hamilton Depression Rating Scale (HAMD-6) of 8 or higher, assessed at screening visit * No medication changes or psychiatric hospitalization in the past month (30 days prior to informed consent) * No planned medication changes or psychotherapy treatment changes for duration of trial * At least one attempt with a antidepressant medication * Agree to consume the same amount of caffeine-containing beverages that they usually consume before arriving at the res…
1-30mg
FDA-approved dosage
FDA approved dosage
FDA-approved dosage