Anxiety & Depression Association of America

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 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).

Condition

Major Depressive Disorder

Eligibility

Eligible Ages: Between 21 Years and 60 Years
Eligible Genders: 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: Early Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase I of the study involves an open trial of 12 participant (i.e., all participants receive psilocybin-assisted cognitive behavioral therapy; PA-CBT). Phase II involves randomization of 50 participants (1:1) to either PA-CBT or psilocybin-assisted therapy with minimal therapeutic support.
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

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).	Drug: Psilocybin Participants will receive two doses of psilocybin (10mg, 25mg). Behavioral: Cognitive behavioral therapy Twelve total sessions of therapy, including manualized cognitive behavioral therapy for major depressive disorder, including psychoeducation about depression, cognitive skills, and behavioral skills as well as preparation for psilocybin.
Active Comparator Psilocybin + Minimal supportive therapy	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).	Drug: Psilocybin Participants will receive two doses of psilocybin (10mg, 25mg). Behavioral: Minimal therapeutic support Six total therapy sessions. Preparation for psilocybin in the first three sessions plus supportive, nondirective psychotherapy in the final three sessions.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of California, Los Angeles

Study Contact

Anabel Salimian
310-906-0917
asalimian@mednet.ucla.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.