A Randomized Placebo Controlled Clinical Trial of Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents Ages 6-17 With Bipolar Spectrum Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)
研究概览
简要总结
This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as follows:
Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of children and adolescents with BPD
Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active omega-3 treatment
详细描述
Initial clinical evidence suggests that the omega-3 fatty acids EPA (eicosapentaenoic acid) and/or DHA (docosahexaenoic acid) may play a therapeutic role in the management of mood disorders. EPA is an essential fatty acid, which can be metabolized to DHA and is a component of the human diet if fish is consumed. Aripiprazole is a novel second general antipsychotic that seems to function as a partial agonist at the dopamine D2 and serotonin 5-HT 1A receptors as well as an antagonist at the serotonin 5-HT 2A receptor. Since it has a favorable adverse event profile in adults, it is an attractive choice for the treatment of youth with bipolar disorder if proven efficacious. Although pilot research showed that omega-3 fatty acids monotherapy treatment resulted in improvement of manic symptoms, the improvement is less dramatic than that observed in trials of antipsychotics. We will test the safety and efficacy of omega-3 fatty acids versus placebo as an adjunctive treatment to open-label aripiprazole in children and adolescents with bipolar disorder.
The proposed study includes 1) the use of a 12-week design to document the response rate 2) careful assessment of safety and tolerability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject, 6-17 years of age
- •Subject has a DSM-IV diagnosis of bipolar I, bipolar II, or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features)
- •Subject and their legal representative have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol
- •Subject and their legal representative must be considered reliable
- •Subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document
- •Subject must have an initial score on the Young-Mania Rating Scale (Y-MRS) of at least 20
- •Subject must be able to participate in mandatory blood draws
- •Subject must be able to swallow pills
- •Subjects with comorbid Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Obsessive Compulsive Disorder (OCD), Pervasive Developmental Disorders (PDD), anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of exclusionary criteria
- •For concomitant therapy used to treat ADHD, subject must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy may not change throughout the duration of the study.
排除标准
- •Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
- •Serious, unstable illness including heptic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
- •Uncorrected hypothyroidism or hyperthyroidism
- •History of sensitivity to omega-3 fatty acids. A non-responder or history of intolerance to omega-3 fatty acid, after treatment at adequate doses as determined by the clinician.
- •Severe allergies or multiple adverse drug reactions.
- •Non-febrile seizures without a clear and resolved etiology
- •DSM-IV substance (except nicotine or caffeine) dependence within past 6 months
- •Judged clinically to be at serious suicidal risk
- •Any other concomitant medication with primarily central nervous system activity other than specified in the Concomitant Medication portion of the protocol.
- •Current diagnosis of schizophrenia
- •Pregnant or nursing females
研究组 & 干预措施
Aripiprazole plus Fish Oil
Subjects administered aripiprazole and randomized to receive fish oil
干预措施: Aripiprazole (Drug)
Aripiprazole plus Fish Oil
Subjects administered aripiprazole and randomized to receive fish oil
干预措施: fish oil (Dietary Supplement)
Aripiprazole plus Placebo
Subjects administered aripiprazole and randomized to receive placebo
干预措施: Aripiprazole (Drug)
Aripiprazole plus Placebo
Subjects administered aripiprazole and randomized to receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)
时间窗: weekly for 1st 6 weeks then biweekly
The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.
次要结局
- DSM-IV Mania Symptom Checklist(weekly for first 6 weeks then biweekly)
研究者
Janet Wozniak, MD
Assistant Professor of Psychiatry at Harvard Medical School and at Massachusetts General Hospital
Massachusetts General Hospital