Psilocybin-Assisted Cognitive Behavioral Therapy for Depression
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Client Satisfaction Questionnaire - 8
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Experimental: Psilocybin + CBT
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).
干预措施: Psilocybin (drug) (Drug)
Experimental: Psilocybin + CBT
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).
干预措施: cognitive behavioral therapy (Behavioral)
Psilocybin + Minimal supportive therapy
Participants will receive 6 sessions of supportive, non-directive therapy along with two psilocybin-drug sessions -- the first following the third therapy session (10mg of psilocybin, taken orally) and the second following the fourth therapy session (25mg of psilocybin, taken orally).
干预措施: Psilocybin (drug) (Drug)
Psilocybin + Minimal supportive therapy
Participants will receive 6 sessions of supportive, non-directive therapy along with two psilocybin-drug sessions -- the first following the third therapy session (10mg of psilocybin, taken orally) and the second following the fourth therapy session (25mg of psilocybin, taken orally).
干预措施: Minimal supportive therapy (Behavioral)
结局指标
主要结局
Client Satisfaction Questionnaire - 8
时间窗: 4-month treatment period
Treatment acceptability as measured by the participant. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Retention/Attrition
时间窗: 4-month treatment period
Feasibility as measured by the number of participants retained in each treatment condition over the course of the study treatment
Hamilton Depression Rating Scale
时间窗: 7-month study period
symptom severity scored from 0-53, with larger values indicating greater depressive severity
Global Assessment of Functioning
时间窗: 7-month study period
psychosocial functioning scored from 0-100, with larger values indicating better functioning
次要结局
未报告次要终点
研究者
Marc J. Weintraub, PhD
Assistant Professor
University of California, Los Angeles