Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Percentage Change of the BOLD Signal
研究概览
简要总结
This is a randomised double-blind clinical trial. The aim is to compare the efficacy and mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms', with the selective serotonin reuptake inhibitor (SSRI) escitalopram for major depressive disorder (MDD).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive disorder (DSM-IV)
- •Depression of moderate to severe degree (17+ on the 17-item Hamilton Depression Scale (HAM-D)).
- •No Magnetic Resonance Imaging (MRI) contraindications
- •No SSRI contraindications
- •Has a general practitioner (GP) or other mental healthcare professional who can confirm diagnosis
- •18-80 years of age
- •Males and females
- •Sufficiently competent with English language
- •Key exclusion criteria:
- •Current or previously diagnosed psychotic disorder
- •Immediate family member with a diagnosed psychotic disorder
- •Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. creatine clearance:renal clearance (CLRC) < 30 ml/min etc.)
- •History of serious suicide attempts requiring hospitalisation.
- •Significant history of mania (determined by study psychiatrist and medical records)
- •Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder
- •Blood or needle phobia
- •Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.
- •Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
- •Current drug or alcohol dependence
- •No email access
- •Use of contraindicated medication
- •Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)
排除标准
- 未提供
研究组 & 干预措施
Psilocybin
Patients receive Psilocybin
干预措施: Psilocybin + Placebo (Drug)
Escitalopram
Patients receive Escitalopram
干预措施: Psilocybin + Escitalopram (Drug)
结局指标
主要结局
Percentage Change of the BOLD Signal
时间窗: Baseline measure vs 6 weeks post 1st psilocybin dosing
Patients were tested with functional magnetic resonance imaging (fMRI) to measure brain brain responses to emotional faces before and after the treatment. The 2 values of BOLD signal (before and after exposure to emotional faces) were used to estimate a percentage value per patient and then these were used to estimated a group percentage change.
Change in QIDS-16: Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-16)
时间窗: Baseline vs 6 weeks post 1st psilocybin dosing
Change in QIDS-16 (self-rated measure of depressive symptoms). Scale is composed of 16 items that correlate with the 9 Diagnostic Statistical Manual (DSM-IV) symptom criteria for depression. Each response is graded 0-4 (none-severe symptoms). Questions 1-4 concern sleep disturbances, Question 5 addresses sad mood, Questions 6-9 appetite/weight, Question 10 concentration, Question 11 self-criticism, Question 12 suicidal ideation, Question 13 interest, Q14 energy/fatigue and Questions 15-16 psychomotor agitation/retardation. All questions that address the same topic are grouped and only the highest score from each group is summed up together with the other questions in order to produce a total score. Scores can range from 0-27 and depression severity is graded based on the total score in the following way: 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression Lower score =better outcome (less depression)
次要结局
- Change in Hamilton Depression Scale (HAMD-17)(Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose)
- Change in Beck Depression Inventory (BDI-IA)(Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose)
- Change in MADRS(Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose)
- Number of Patients Who "Responded": Quick Inventory of Depressive Symptomatology (QIDS-16) Response at 6 Weeks(Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose)
- Number of Patients Who "Remitted": QIDS-16 Remission Rate(Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose)