Psilocybin-assisted CBT for Depression

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05227612
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 41

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Psilocybin	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Psilocybin-assisted Cognitive Behavioral Therapy for Depression
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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).	Drug: Psilocybin; Participants will receive two doses of psilocybin (10mg, 25mg) as well as 12 sessions of CBT.

Outcome Measures

Primary Outcome Measures

1. Hamilton Depression Rating Scale [7-month study period]

   symptom severity scored from 0-53, with larger values indicating greater depressive severity

2. Global Assessment of Functioning [7-month study period]

   psychosocial functioning scored from 0-100, with larger values indicating better functioning

3. Treatment acceptability [4-month treatment period]

   participant and clinician feedback related to the joining of psilocybin with CBT

4. Treatment feasibility [4-month treatment period]

   recruitment and retention of participants in the trial

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marc J. Weintraub, PhD, Clinical Instructor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT05227612
• Other Study ID Numbers: 21-002134
• First Posted: Feb 7, 2022
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marc J. Weintraub, PhD, Clinical Instructor, University of California, Los Angeles: psilocybin; cognitive behavioral therapy (CBT)
• Additional relevant MeSH terms: Depressive Disorder; Depressive Disorder, Major; Psilocybin

Study Results

No Results Posted as of Jul 25, 2022