Psilocybin-assisted CBT for Depression

• ClinicalTrials.gov Identifier: NCT05227612
• Recruitment Status: Not yet recruiting
• First Posted: February 7, 2022
• Last Update Posted: February 22, 2022
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Marc J. Weintraub, PhD, University of California, Los Angeles

Tracking Information

• First Submitted Date: January 26, 2022
• First Posted Date: February 7, 2022
• Last Update Posted Date: February 22, 2022
• Estimated Study Start Date: September 2022
• Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 4, 2022)

• Hamilton Depression Rating Scale [ Time Frame: 7-month study period ]
  symptom severity scored from 0-53, with larger values indicating greater depressive severity
• Global Assessment of Functioning [ Time Frame: 7-month study period ]
  psychosocial functioning scored from 0-100, with larger values indicating better functioning
• Treatment acceptability [ Time Frame: 4-month treatment period ]
  participant and clinician feedback related to the joining of psilocybin with CBT
• Treatment feasibility [ Time Frame: 4-month treatment period ]
  recruitment and retention of participants in the trial

Original Primary Outcome Measures (submitted: January 26, 2022)

• Hamilton Depression Rating Scale [ Time Frame: 7-month study period ]
  symptom severity
• Global Assessment of Functioning [ Time Frame: 7-month study period ]
  psychosocial functioning
• Treatment acceptability [ Time Frame: 4-month treatment period ]
  participant and clinician feedback related to the joining of psilocybin with CBT
• Treatment feasibility [ Time Frame: 4-month treatment period ]
  recruitment and retention of participants in the trial

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Psilocybin-assisted CBT for Depression
• Official Title: Psilocybin-assisted Cognitive Behavioral Therapy for Depression
• Brief Summary: The primary objectives of this clinical investigation are to (1) determine the feasibility of joining psilocybin treatment with CBT (cognitive-behavioral therapy) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) determine the initial efficacy of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. Psilocybin will be administered orally in two doses during the course of 12 sessions of CBT to eligible study participants - a 10mg dose following the third session and a 25mg dose following the sixth session. Participants will be in active treatment for the first 4 months (psilocybin + CBT) of the study and then followed for an additional 3-months following the termination of CBT.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

Drug: Psilocybin

Participants will receive two doses of psilocybin (10mg, 25mg) as well as 12 sessions of CBT.

Study Arms

Experimental: Psilocybin + CBT

All 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).

Intervention: Drug: Psilocybin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 26, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2026
• Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05227612
• Other Study ID Numbers: 21-002134
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Marc J. Weintraub, PhD, University of California, Los Angeles
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, Los Angeles
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of California, Los Angeles
• Verification Date: January 2022