Clinical trial NCT05227612: Psilocybin-assisted CBT for Depression
Official title: Psilocybin-assisted Cognitive Behavioral Therapy for Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Major Depressive Disorder
Keywords: psilocybin
cognitive behavioral therapy (CBT)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-02-07
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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).


Eligibility criteria: 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

Primary outcomes:
measure: Treatment acceptability
timeFrame: 4-month treatment period
measure: Treatment feasibility
timeFrame: 4-month treatment period
measure: Hamilton Depression Rating Scale
timeFrame: 7-month study period
measure: Global Assessment of Functioning
timeFrame: 7-month study period
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
References: