Psilocybin-assisted CBT for Depression

Study Overview
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Brief Summary
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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.

Official Title
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Psilocybin-assisted Cognitive Behavioral Therapy for Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psilocybin + CBT<br>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<br>* Participants will receive two doses of psilocybin (10mg, 25mg) as well as 12 sessions of CBT.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psilocybin, cognitive behavioral therapy (CBT)