A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms
研究概览
简要总结
This research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19-65 years
- •Bipolar disorder I or II (DSM-IV-TR) with current depressive episode
- •Informed consent
排除标准
- •Use of medication for bipolar depression or other psychotropic drugs
- •Current Axis I mental disorders other than bipolar depression based on structured clinical interview
- •Current borderline or antisocial personality disorder based on structured clinical interview
- •Major medical or neurological illnesses (epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc)
- •Hypersensitivity to divalproate or valpromide
- •Diagnosis of porphyria
- •Current or past liver diseases
- •Severe dysfunction in liver or pancreas
- •Use of mefloquine
- •Alcohol or substance abuse/dependence
- •Intelligence quotient of 80 or below
- •Contraindications to magnetic resonance imaging
- •Pregnancy or breastfeeding
- •Allergy or intolerance to the study drugs
研究组 & 干预措施
Valproate and Placebo
Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks
干预措施: Valproate and Placebo (Drug)
Valproate and Cytidine-containing Drug
Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks
干预措施: Valproate and Cytidine-containing Drug (Drug)
Valproate and Creatine-containing Drug
Valproate: 300mg/day for 8 weeks Creatine-containing Drug: 3g/day for the first week 5g/day for week 2-8
干预措施: Valproate and Creatine-containing Drug (Drug)
结局指标
主要结局
Change in depressive symptoms
时间窗: Baseline and 8 weeks
assessed with structured clinical interview
Change in symptoms of bipolar depression
时间窗: Baseline and 8 weeks
assessed with structured clinical interview
次要结局
- Change in brain Glx (glutamate+glutamine) level(Baseline and 8 weeks)
- Change in brain phosphocreatine level(Baseline and 8 weeks)
- Number of participants with adverse events(Baseline through 8 weeks)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University Mokdong Hospital