Psilocybin-assisted CBT for Depression
Purpose
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 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.
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 21 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- • 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 Criteria
- • 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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This study involves an open trial of 12 participant (i.e., all participants receive psilocybin-assisted cognitive behavioral therapy; PA-CBT).
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Psilocybin + CBT |
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). |
|
More Details
- Status
- Completed
- Sponsor
- University of California, Los Angeles
