Psilocybin-assisted therapy for depression
Psilocybin-assisted Cognitive Behavioral Therapy for Depression
This study is testing if combining psilocybin with cognitive-behavioral therapy can help people with major depression feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05227612 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the acceptability and feasibility of combining psilocybin with cognitive-behavioral therapy (CBT) for individuals suffering from major depressive disorder. The study consists of two phases: the first phase involves an open trial where participants receive two doses of psilocybin alongside 12 sessions of CBT. The second phase will be a randomized trial assessing the adherence and effectiveness of this combined treatment approach. The goal is to optimize the integration of the psilocybin experience with psychotherapy to enhance clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-60 with a current major depressive episode and active depressive symptoms.
Not a fit: Patients with a personal or family history of psychosis or bipolar disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with major depressive disorder.
How similar studies have performed: Other studies exploring psilocybin-assisted therapies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- UCLA Semel Institute — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Shelby Grody
- Email: UCLAPAT@mednet.ucla.edu
- Phone: 310-825-4354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.