A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy for Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- MADRS (Montgomery-Asberg Depression Rating Scale)
研究概览
简要总结
The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.
详细描述
Bipolar Depression is associated with high rates of disability and increased mortality. Despite its major negative impact, treatment of Bipolar Depression is still controversial and only partially efficacious, with over half of patients not responding adequately to available treatment. In this context, the use of drugs that modulate energy metabolism has been proposed as promising new option as treatment strategies for bipolar depression. The aim of our proposed study is to perform a 6-week randomized, double-blind, placebo-controlled clinical trial of creatine monohydrate as an adjuvant treatment for bipolar depression.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals eligible for the study will be adults aged 18 to 60 years of age who met DSM-IV criteria assessed by the SCID (Structural Clinical Interview for DSM-IV) for type I bipolar disorder, current episode depressed.
- •Patients who have scored > 19 on the Montgomery-Asberg Depression Rating Scale (MADRS) will be included, although more than two weeks of treatment with lithium (serum level> 0.8 mEq / L), valproate (serum levels> 50 mg / L) or quetiapine (300-600mg/dia dose) or drug combination.
- •Antipsychotics, anticonvulsants, benzodiazepines, and thyroid supplementation will be allowed if the dose has remained stable over the past two weeks.
- •Antidepressants will be allowed if the dosage has remained stable for 4 weeks.
排除标准
- •Subjects with substance abuse within 2 weeks before inclusion or substance dependence up to 2 months will not be included.
- •Other exclusion criteria will be:
- •diagnosis of schizophrenia,
- •dementia,
- •delirium,
- •epilepsy,
- •mental retardation,
- •clinically unstable medical illnesses,
- •preexisting renal disease,
- •history of hypersensibility to creatine.
- •Not included are individuals at high risk for suicidal or homicidal behavior or self-mutilation will not be included.
- •Women with gestational potential can only be included if they are using reliable contraception.
结局指标
主要结局
MADRS (Montgomery-Asberg Depression Rating Scale)
时间窗: 6 weeks
change of score on the Montgomery-Asberg Depression Rating Scale
次要结局
- HDRS-17 (Hamilton Depression Rating Scale - 17-item version)(6 weeks)
研究者
Ricardo Alexandre Toniolo
MD
University of Sao Paulo