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RecruitingPhase 1 / Phase 2

RCT of Psilocybin-assisted CBT for Depression

Psilocybin-Assisted Cognitive Behavioral Therapy for Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests psilocybin with cognitive behavioral therapy (CBT), a talk therapy that helps people change unhelpful thoughts and actions. It is for adults ages 21–60 who have depression symptoms now and a current or past major depression episode. Researchers will compare two therapy plans to see how well they work and how easy they are to follow; both include two doses of psilocybin.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 21–60 years old.
  • You can swallow capsules.
  • You have a current or past major depression episode that meets standard diagnosis rules.
  • You have depression symptoms now, with a score above 16 on the study’s depression scale for the past 2 weeks.
  • You have a support person who can pick you up at UCLA Semel Institute and drive you home after psilocybin sessions.
  • If you are a woman who can become pregnant, you use highly effective birth control and will keep using it during the study.
  • A doctor has cleared you to take part.

Who can't join

  • You or a close family member have a history of psychosis (trouble knowing what is real) or bipolar disorder (episodes of extreme mood changes).
  • You have narcissistic, histrionic, borderline, or antisocial personality disorder; current suicide risk based on the study’s scale; or another mental health problem needing urgent treatment.
  • You take antidepressants or other substances that affect serotonin, a brain chemical, such as St. John’s Wort or 5-HTP; or you are currently getting CBT.
  • Your resting blood pressure averages above 140 for the top number or 90 for the bottom number across four readings, or you have a serious heart or blood vessel condition.
  • You have had a stroke or TIA (a brief stroke-like event), have epilepsy or a history of seizures, or have diabetes that requires insulin.
  • You have met the study’s rules for a substance use disorder in the past 6 months, or your urine test shows illegal drugs.
  • You have used other psychedelics or ketamine in the past 12 months, or have had a bad reaction to a psychedelic drug.
  • You are pregnant, trying to become pregnant, or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA