Status:
COMPLETED
Psilocybin-assisted CBT for Depression
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
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 patie...
Eligibility Criteria
Inclusion
- • 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.
Exclusion
- • 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
Key Trial Info
Start Date :
June 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05227612
Start Date
June 27 2023
End Date
September 12 2025
Last Update
December 12 2025
Active Locations (1)
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1
UCLA Semel Institute
Los Angeles, California, United States, 90095