跳至主要内容
临床试验/ACTRN12606000440527
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.

研究者

发起方
Professor Philip Hazell

相似试验