COMPLETED

Psilocybin-assisted CBT for Depression

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Conditions

Major Depressive Disorderpsilocybincognitive behavioral therapy (CBT)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Psilocybin-assisted Cognitive Behavioral Therapy for Depression

Quick Facts

Study Start:2023-06-27
Study Completion:2025-09-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05227612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Ages 21-60,
  2. * Able to swallow capsules,
  3. * Patients with a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),
  4. * Active current depressive symptoms (i.e., scores \>16 on the Hamilton-Depression Rating Scale (HAM-D) covering the prior 2 weeks; Hamilton, 1986),
  5. * Have an identified support person who can pick up the individual from UCLA Semel Institute and drive individual home following psilocybin sessions,
  6. * 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
  7. * Patient has been medically cleared for the study by a physician.
  1. * • A personal or family history (first or second-degree) of psychosis or bipolar disorder
  2. * Resting blood pressure above 140 systolic, 90 diastolic (averaged across four separate measurements)
  3. * Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),
  4. * Active suicidality (as indicated by a 3 or greater on item 3 of the HAM-D) or other psychiatric disturbance requiring acute treatment
  5. * Current use of antidepressants or other serotonergic-affecting substances (e.g., St. John's Wort and 5-hydroxytryptophan),
  6. * Currently receiving cognitive behavioral therapy,
  7. * 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
  8. * A history of stroke or Transient Ischemic Attack (TIA)
  9. * Epilepsy or history of seizures
  10. * Insulin-dependent diabetes
  11. * Meeting criteria for a DSM-5 substance abuse or dependence within prior 6 months
  12. * Positive urine drug screen for illicit substances
  13. * Use of other psychedelics or ketamine within prior 12 months
  14. * Adverse prior reaction to a psychedelic agent
  15. * Pregnant, trying to get pregnant, or nursing

Contacts and Locations

Study Locations (Sites)

UCLA Semel Institute
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-27
Study Completion Date2025-09-12

Study Record Updates

Study Start Date2023-06-27
Study Completion Date2025-09-12

Terms related to this study

Keywords Provided by Researchers

  • psilocybin
  • cognitive behavioral therapy (CBT)

Additional Relevant MeSH Terms

  • Major Depressive Disorder