RCT of Psilocybin-assisted CBT for Depression
ConditionMajor Depressive Diorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21-60
SponsorUniversity of California, Los Angeles
About this trial
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 is 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
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin (drug)
DrugParticipants will receive two doses of psilocybin (10mg, 25mg).
cognitive behavioral therapy
BehavioralTwelve total sessions of therapy, including manualized cognitive behavioral therapy for major depressive disorder, including psychoeducation about depression, cognitive skills, and behavioral skills as well as preparation for psilocybin.
Minimal supportive therapy
BehavioralSix total therapy sessions. Preparation for psilocybin in the first three sessions plus supportive, nondirective psychotherapy in the final three sessions.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Experimental: Psilocybin + CBTExperimental treatment 2 interventions
Group B: Psilocybin + Minimal supportive therapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Client Satisfaction Questionnaire - 8
Treatment acceptability as measured by the participant. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame
4-month treatment period2
Retention/Attrition
Feasibility as measured by the number of participants retained in each treatment condition over the course of the study treatment
Time frame
4-month treatment period3
Hamilton Depression Rating Scale
symptom severity scored from 0-53, with larger values indicating greater depressive severity
Time frame
7-month study period4
Global Assessment of Functioning
psychosocial functioning scored from 0-100, with larger values indicating better functioning
Time frame
7-month study periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov