Back to resultsPsilocybin-assisted CBT for Depression
Primary Purpose
Major Depressive Disorder
Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring psilocybin, cognitive behavioral therapy (CBT)
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
Sites / Locations
- UCLA Semel Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psilocybin + CBT
Arm Description
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).
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale
symptom severity scored from 0-53, with larger values indicating greater depressive severity
Global Assessment of Functioning
psychosocial functioning scored from 0-100, with larger values indicating better functioning
Treatment acceptability
participant and clinician feedback related to the joining of psilocybin with CBT
Treatment feasibility
recruitment and retention of participants in the trial
Secondary Outcome Measures
Full Information
NCT ID
NCT05227612
First Posted
January 26, 2022
Last Updated
July 11, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT05227612
Brief Title
Psilocybin-assisted CBT for Depression
Official Title
Psilocybin-assisted Cognitive Behavioral Therapy for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
psilocybin, cognitive behavioral therapy (CBT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psilocybin + CBT
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Participants will receive two doses of psilocybin (10mg, 25mg) as well as 12 sessions of CBT.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
symptom severity scored from 0-53, with larger values indicating greater depressive severity
Time Frame
7-month study period
Title
Global Assessment of Functioning
Description
psychosocial functioning scored from 0-100, with larger values indicating better functioning
Time Frame
7-month study period
Title
Treatment acceptability
Description
participant and clinician feedback related to the joining of psilocybin with CBT
Time Frame
4-month treatment period
Title
Treatment feasibility
Description
recruitment and retention of participants in the trial
Time Frame
4-month treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UCLA Semel Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Psilocybin-assisted CBT for Depression
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