Major Depressive Disorder
Conditions
Keywords
psilocybin, cognitive behavioral therapy (CBT)
Brief 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 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.
Interventions
DRUGPsilocybin
Participants will receive two doses of psilocybin (10mg, 25mg).
BEHAVIORALCognitive behavioral therapy
Twelve 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.
Sponsors
University of California, Los Angeles
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study involves an open trial of 12 participant (i.e., all participants receive psilocybin-assisted cognitive behavioral therapy; PA-CBT).
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Acceptability (Client Satisfaction Questionnaire-8) | 4-month treatment period | Participant feedback related to the treatment on the Client Satisfaction Questionnaire-8. Scores can range from 8-32 with higher scores indicating greater satisfaction. |
| Study Feasibility (Number of Participants That Completed the 4-month Treatment) | 4-month treatment period | Retention of participants in the trial |
| Hamilton Depression Rating Scale (HAM-D) | Baseline, Post-treatment (an average of 4 months), and 3-month follow-up (an average of 7-months) | Symptom severity scored from 0-53, with larger values indicating greater depressive severity, as measured repeatedly at the baseline assessment |
| Global Assessment of Functioning (GAF) | Baseline, Post-treatment (an average of 4 months), and 3-month follow-up (an average of 7-months) | psychosocial functioning scored from 0-100, with larger values indicating better functioning |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 15 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
None listed