Psilocybin-assisted CBT for Depression

Major Depressive Disorder Clinical Trial

Official title:

Psilocybin-assisted Cognitive Behavioral Therapy for Depression

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05227612
• Other study ID #: 21-002134
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: June 27, 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	UCLA Semel Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

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