NCT01543139撤回2 期
A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-Containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from baseline in depressive symptom scores at 4 weeks
研究概览
简要总结
This proposed research is aimed to investigate the efficacy and safety of combined cytidine- and creatine-containing drug and dietary supplement in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using 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
- •19-65 year-old male or female
- •Bipolar depression diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
- •Written informed consent
排除标准
- •Present use of drugs for bipolar depression or any psychotropic medication
- •Use of psychoactive medication that may affect brain imaging findings
- •Diagnosis of any other axis I psychiatric disorder
- •Presence of borderline personality disorder or antisocial personality disorder
- •Presence of any major physical or neurological illness (e.g., epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc.)
- •Hypersensitivity to divalproate, valpromide or diagnosis of porphyria
- •Past or current liver disease, current severe liver or pancreas dysfunction
- •Currently taking mefloquine
- •Presence of alcohol or drug dependence, drug abuse
- •Intelligence quotient below 80
- •Contraindications to magnetic resonance imaging
- •Women who are pregnant, breastfeeding, or planning pregnancy
- •Allergy or intolerance to the study drugs
研究组 & 干预措施
Valproate+Cytidine-+Creatine-
Experimental
The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate
干预措施: Valproate+Cytidine-+Creatine- (Drug)
Valproate+Cytidine-
Active Comparator
The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate
干预措施: Valproate+Cytidine- (Drug)
Valproate
Active Comparator
The subjects with bipolar depression, treated with valproate
干预措施: Valproate (Drug)
结局指标
主要结局
Change from baseline in depressive symptom scores at 4 weeks
时间窗: Baseline and at 4 weeks
Change from baseline in depressive symptom scores at 8 weeks
时间窗: Baseline and at 8 weeks
次要结局
- Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks(Baseline and at 8 weeks)
- Number of participants with adverse events(8 weeks)
- Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks(Baseline and at 8 weeks)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University
研究点 (1)
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