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Psilocybin-assisted CBT for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05227612
Recruitment Status : Not yet recruiting
First Posted : February 7, 2022
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
Marc J. Weintraub, PhD, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE January 26, 2022
First Posted Date  ICMJE February 7, 2022
Last Update Posted Date February 22, 2022
Estimated Study Start Date  ICMJE September 2022
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin-assisted CBT for Depression
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Psilocybin
Participants will receive two doses of psilocybin (10mg, 25mg) as well as 12 sessions of CBT.
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2022)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05227612
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party Marc J. Weintraub, PhD, University of California, Los Angeles
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Los Angeles
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Los Angeles
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP