Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)
研究概览
简要总结
The primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder. The primary hypothesis is that psilocybin will result in neuroplastic changes that parallel improvement in symptoms of depression.
详细描述
In this placebo-controlled, blinded study, individuals with depression will participate in 2 experimental sessions approximately 4 weeks apart during which they will receive two of the following three interventions: 1) placebo, 2) low dose psilocybin (0.1 mg/kg), and 3) medium dose psilocybin (0.3 mg/kg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and currently experiencing a Major Depressive Episode (MDE)
- •Failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode
- •Currently engaged in treatment with a mental health clinician
排除标准
- •Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
- •Axis I psychotic disorder in first degree relative
- •Currently taking a conventional antidepressant medication
- •Unstable medical or neurological conditions
- •Significant cognitive disorders
- •History of intolerance to drugs known to significantly alter perception e.g., psilocybin, LSD, salvinorin A, mescaline, etc.
- •Pregnant, breastfeeding, lack of adequate birth control
- •Urine toxicology positive to drugs of abuse on experimental test days
研究组 & 干预措施
Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
干预措施: Low Dose Psilocybin (Drug)
Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
干预措施: Placebo (Drug)
Placebo/Medium Dose Psilocybin
Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.
干预措施: Placebo (Drug)
Placebo/Medium Dose Psilocybin
Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.
干预措施: Medium Dose Psilocybin (Drug)
Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
干预措施: Low Dose Psilocybin (Drug)
Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
干预措施: Placebo (Drug)
Medium Dose Psilocybin/Placebo
Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.
干预措施: Placebo (Drug)
Medium Dose Psilocybin/Placebo
Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.
干预措施: Medium Dose Psilocybin (Drug)
结局指标
主要结局
Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)
时间窗: One day and two weeks after each experimental session
An auditory Long Term Potentiation (LTP) task will assess changes in neuroplasticity. For the EEG task, the outcome measures will include stimulus-evoked time x frequency analysis (e.g., spectral power)
次要结局
- Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ](One day and two weeks after each experimental session)
- Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)(Four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.)
- Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16)(Four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.)
研究者
Deepak C. D'Souza
Professor of Psychiatry
Yale University