ACTRN12606000440527已完成不适用
An open-label study to evaluate the effects of omega-3 polyunsaturated fatty acids delivered in tuna oil in the treatment of children and adolescents with bipolar disorder to improve symptoms of mania and depression
Professor Philip Hazell0 个研究点目标入组 20 人开始时间: 2006年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 8 Years 至 18 Years(—)
- 性别
- All
入选标准
- •Meet diagnostic criteria for either BAD I, BAD II or BAD-NOS as specified in the DSM-IV-TR (APA, 2000).• Have had an episode of mania, hypomania, mixed mania or major depression in the preceding 6 months• Are currently being prescribed either a mood stabilising medication, an atypical antipsychotic medication or a combination of both medication groups. • Males and Females between 8-18 years at initial assessment.
排除标准
- •Primary medical or neurological cause of the mood disorder• Comorbid diagnosis of Autistic Spectrum Disorder or clinically evident mental retardation.• Comorbid diagnosis of a significant medical disorder, such as active hepatic or renal disease, dementia, serious head injury or active cancer.• Diagnosed with Non-Insulin Dependent Diabetes Mellitus (NIDDM) - type 2 diabetes.• Diagnosed with any cardiovascular, haematological or gastrointestinal disease.• Have taken fish oil (omega-3 fatty acids) as supplements within the previous 6 weeks. • Are receiving any concomitant medications that affect lipid metabolism, such as HMG-CoA inhibitors or high-dose niacin.• Patients receiving drugs which affect blood coagulation due to the theoretical risk of bleeding during LC n-3 fa supplementation.• Are pregnant.• Have a body mass index (BMI) less than 16 or greater than 30.• Actively consuming a low fat diet.
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