A Randomized Controlled Trial of the Fatty Acid Amide Hydrolase Inhibitor Palmitoylethanolamide in Bipolar Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Depression as Assessed by the Hamilton Depression Rating Scale (HAM-D)
研究概览
简要总结
The purpose of this study is to o evaluate the antidepressant efficacy of the PEA in Bipolar Depression and the association between antidepressant response with endogenous cannabinoids and cytokine levels
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Bipolar Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Structured Clinical Interview), Fifth Edition, (DSM5), with a score of ≥16 on the 17-item HAM-D
- •currently in use of at least one FDA approved mood stabilizer with or without antidepressant
- •medically and neurologically healthy on the basis of medical history, physical examination
排除标准
- •Cannabis misuse according to clinical judgement
- •unstable medical condition or uncontrolled medical problem with known central nervous system (CNS) effects
- •active DSM-5 substance use disorder in past three months (other than alcohol or nicotine use disorder)
- •acute high suicidal risk
- •in a manic episode
- •current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examination
- •pregnant or nursing women
- •unstable medical conditions
- •clinically significant abnormal laboratory tests based on complete blood count, liver and kidney function when available
研究组 & 干预措施
Placebo plus Treatment as Usual (TAU)
干预措施: Placebo (Drug)
Placebo plus Treatment as Usual (TAU)
干预措施: Treatment as Usual (TAU) (Drug)
PEA plus Treatment as Usual (TAU)
干预措施: Treatment as Usual (TAU) (Drug)
PEA plus Treatment as Usual (TAU)
干预措施: Palmitoylethanolamide (PEA) (Drug)
结局指标
主要结局
Change in Depression as Assessed by the Hamilton Depression Rating Scale (HAM-D)
时间窗: Baseline, 6 weeks follow up
The Hamilton Depression Rating Scale measures severity of depression. The total score ranges from 0 to 26, higher score indicating greater depression severity. The change in score will be reported. The change in score will be reported as the \[(Score at 6 weeks follow up) - (Score at Baseline)\] - A negative value indicates improvement of depression severity.
次要结局
- Number of Participants That Show a Remission of Depressive Symptoms as Assessed by the HAM-D Scale(from baseline to end of study (6 week follow up))
- Number of Participants That Show a Response as Assessed by the HAM-D Scale(from baseline to end of study (6 week follow up))
- Change in Depression as Assessed by the Montgomery Äsberg Depression Rating Scale (MADRS)(Baseline, 6 weeks follow up)
- Time to Response - HAM-D (≥50% Reduction From Baseline)(Baseline To Week 6)
研究者
Rodrigo Machado-Vieira, MD, PhD, MSc
Professor
The University of Texas Health Science Center, Houston