psilocybin-assisted cbt for depression

Conditions: Major Depressive Disorder

Summary: the primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (pa-cbt) for patients with depression, (2) optimize cbt to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (cbt) for major depressive disorder. this study has two phases. phase i will involve an open trial of pa-cbt where participants will receive two doses of psilocybin (10mg and then 25mg, separated by one month) plus 12 sessions of cognitive behavioral therapy. phase ii will be a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to pa-cbt. both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). in phase ii, participants will be randomized (1:1) to either a 12-session pa-cbt or a 6-session standard psilocybin-assisted therapy (pat) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).


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

Keywords: psilocybin cognitive behavioral therapy (cbt)