A Preliminary Clinical Study on the Rapid Antidepressant Effects of Adenosine Triphosphate (ATP) and Phosphocreatine Combinated With Fluoxetine
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Changes in Hamilton depression rating scale during the first six weeks
研究概览
简要总结
This is a preliminary, double-blind clinical trail aimed to investigate whether the combination of fluoxetine with ATP or phosphocreatine has a rapid antidepressant effect. 42 patients with major depressive disorder (Hamilton Depression Rating Scale (HAMD) score >= 20) will be recruited and divided into 3 groups randomly. This study involves two periods. In the first period, one group will be treated with fluoxetine and placebo, one with fluoxetine and ATP, and one with fluoxetine and phosphocreatine for 2 weeks. Placebo, ATP and phosphocreatine will be given intravenously, and fluoxetine orally. In the second period, each patient will be only given fluoxetine for 4 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 year-old male or female
- •Major depressive disorder diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •Hamilton depression rating scale score >= 20 at screening
- •Written informed consent
排除标准
- •Participants of other clinical trials in recent 4 weeks
- •Suicidal idea or action that requires hospitalization
- •Post Traumatic Stress Syndrome in recent 6 months
- •Secondary depression, or have a direct familial history of schizophrenia
- •Diseases that prevent from appropriate expression of depressive emotion
- •Psychiatric disorders including bipolar disorder and schizophrenia
- •Severe heart, kidney, lung or liver diseases that require hospitalization
- •Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
- •Inflammatory disease including autoimmune disease
- •Taking anti-inflammatory medication
- •Taking antiarrhythmic drugs, antidiabetic agents or tryptophan
- •Substance abuse or dependence history in recent 6 months
- •Pregnant or having plan to be pregnant
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
ATP
干预措施: ATP (Drug)
phosphocreatine
干预措施: Phosphocreatine (Drug)
结局指标
主要结局
Changes in Hamilton depression rating scale during the first six weeks
时间窗: baseline, 1st, 2nd, 4th, 6th week
次要结局
- Changes in Patient Health Questionnaire (PHQ-9) during the first six weeks(baseline, 1st, 2nd, 4th, 6th week)
- Changes in Clinical global impression scale during the study(baseline, 2nd, 4th, 10th week)
- Side effects assessment during the first six weeks(1st, 2nd, 4th, 6th week)