Psilocybin-assisted CBT for Depression

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Jan 26, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of psilocybin, a substance found in certain mushrooms, combined with cognitive-behavioral therapy (CBT) to help people with major depressive disorder. The study aims to see if this combination can effectively support patients in overcoming their depression and to understand how best to integrate the psilocybin experience into therapy. Participants will receive psilocybin in two doses during their treatment sessions, which will take place over four months, followed by a three-month follow-up period.

To be eligible for this trial, participants must be between 21 and 60 years old, have a current episode of major depression, and be able to swallow capsules. They should also have a support person who can drive them home after the psilocybin sessions. However, individuals with a history of severe mental health conditions, certain medical issues, or those currently using other antidepressants or therapies will not be eligible. If you choose to participate, you can expect a structured treatment program that includes both therapy and the psilocybin sessions, all under careful medical supervision.

Gender

ALL

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