Psilocybin-assisted CBT for Depression
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT05227612
- Lead Sponsor
- University of California, Los Angeles
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 62
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• Ages 21-60,
- Able to swallow capsules,
- Patients with 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 (HAM-D) covering the prior 2 weeks; Hamilton, 1986),
- Have an identified support person 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
- Patient has been medically cleared for the study by a physician.
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• A personal or family history (first or second-degree) of psychosis or bipolar disorder
- Resting blood pressure above 140 systolic, 90 diastolic (averaged across four separate measurements)
- Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),
- Active suicidality (as indicated by a 3 or greater on item 3 of the HAM-D) or other psychiatric disturbance requiring acute treatment
- Current use of antidepressants or other serotonergic-affecting substances (e.g., St. John's Wort and 5-hydroxytryptophan),
- Currently receiving cognitive behavioral therapy,
- Any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition
- A history of stroke or Transient Ischemic Attack (TIA)
- Epilepsy or history of seizures
- Insulin-dependent diabetes
- Meeting criteria for a DSM-5 substance abuse or dependence within prior 6 months
- Positive urine drug screen for illicit substances
- Use of other psychedelics or ketamine within prior 12 months
- Adverse prior reaction to a psychedelic agent
- Pregnant, trying to get pregnant, or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psilocybin + CBT Psilocybin 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). Psilocybin + CBT Cognitive behavioral therapy 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). Psilocybin + Minimal supportive therapy Psilocybin 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). Psilocybin + Minimal supportive therapy Minimal therapeutic support 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).
- Primary Outcome Measures
Name Time Method Treatment feasibility 4-month treatment period recruitment and retention of participants in the trial
Hamilton Depression Rating Scale 7-month study period symptom severity scored from 0-53, with larger values indicating greater depressive severity
Global Assessment of Functioning 7-month study period psychosocial functioning scored from 0-100, with larger values indicating better functioning
Treatment acceptability 4-month treatment period participant and clinician feedback related to the joining of psilocybin with CBT
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCLA Semel Institute
🇺🇸Los Angeles, California, United States