A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.
研究概览
简要总结
Depressive symptoms are associated with significant psychosocial impairment. However, current treatments of bipolar depression are only partially effective.
Cannabidiol is a natural component of cannabis without psychotomimetic or addictive properties. Cannabidiol has been shown to produce therapeutic effects including anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects. The investigators hypothesize that treatment with cannabidiol will result in improvement of depressive and anxiety symptoms, as well as, improvement in functioning and inflammatory biomarkers. During the clinical trial, subjects will receive study medication (cannabidiol 150-300mg/day) or placebo for a period of 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Major depressive episode as part of bipolar I disorder or bipolar II disorder according to Fifth Edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5) and are able to provide written informed consent.
- •Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 12 and MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness) scores ≥ 2 at baseline.
- •Young Mania Rating Scale (YMRS) ≤
- •Currently prescribed lithium or valproic acid and derivates (divalproex sodium, sodium valproate) or atypical antipsychotics at therapeutic dosage for at least 04 weeks before the baseline.
- •Females must test negative for pregnancy and must be using adequate birth control measures throughout the study.
排除标准
- •Another concurrent mental or behavioral disorder that requires psychiatric attention in the past 6 months.
- •Young Mania Rating Scale (YMRS) score >
- •Current or past drug sensitivity/intolerance to cannabidiol.
- •Substance Use Disorder according to DSM-5 within past 6 months, except for nicotine Substance Use Disorder.
- •Clinically significant unstable medical illness, neurological disorders or inflammatory/autoimmune diseases.
- •Any autoimmune, inflammatory or neurologic disorders that requires treatment with steroidal anti-inflammatory medications or immunotherapy with biologic drugs.
- •Actively suicidal or homicidal risk.
- •Females who are pregnant or breastfeeding
研究组 & 干预措施
Cannabidiol
Cannabidiol 150-300mg per day for 12 weeks.
干预措施: Cannabidiol (Drug)
Placebo
Cannabidiol comparator for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.
时间窗: 08 weeks
* Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores. * Scale range: from 0 to 60. * Higher values represent more severe symptoms of depression.
次要结局
- Improvement in clinical global impression.(Up to weeks 08 and 12)
- Improvement in anxiety symptoms(Up to weeks 08 and 12)
- Improvement in functioning.(Up to weeks 08 and 12)
- Change in endocannabinoid levels in the blood.(Up to weeks 08 and 12)
- Change in depressive symptoms(Up to weeks 08 and 12)
- Change in depressive symptoms according to MADRS(Up to week 12)
- Improvement in biological rhythms.(Up to weeks 08 and 12)
- Change in psychotic symptoms(Up to weeks 08 and 12)
- Change in depressive symptoms according to PHQ-9(Up to weeks 08 and 12)
- Change in oxidative stress markers levels in the blood.(Up to weeks 08 and 12)
- Change in BDNF levels in the blood.(Up to weeks 08 and 12)
- Change in inflammatory levels in the blood.(Up to weeks 08 and 12)
- Remission of manic symptoms.(Up to weeks 08 and 12)