Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients.
详细描述
Following acute (6-week) open-label treatment with quetiapine, first-episode adolescent manic patients (ages 10-17 years) were randomized to double-blind adjunctive treatment with long-chain omega-3 (LCn-3) fatty acids or placebo for 24 weeks to investigate protective effects on the of adverse cardiometabolic events and weight gain during quetiapine maintenance therapy. They will have 6 visits over a 24-week period.
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV-TR criteria for bipolar disorder, type I, manic or mixed episode
- •Baseline YMRS score > 20
- •Ages 10-17 years
- •Tanner scale stages III-V
- •No prior exposure to SGA medications
- •Fluent in English
- •Provision of written informed consent by a legal guardian and written assent by the subject
- •Manic or depressive symptoms do not result entirely from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution
- •If female and of child bearing potential, agrees to use one of the following method of birth control: complete abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive. For Phase II, additional Inclusion criteria are
- •Receiving a stable therapeutic dose of quetiapine for a minimum of 1 week (i.e., patients who achieved remission (YMRS total score 7 during Phase I)
- •Not requiring concomitant use of antidepressant or mood-stabilizer medications (see Section C.4.c. Concomitant Medications).
排除标准
- •IQ < 70, as determined by The Wechsler Abbreviated Scale of Intelligence
- •Positive pregnancy test (to avoid teratogenesis)
- •A history of major cardiovascular or neurological illness
- •Any lifetime DSM-IV-TR substance use disorder (nicotine dependence is permitted)
- •A lifetime DSM-IV-TR diagnosis of any pervasive developmental disorder
- •Any history of a hematological disorder in themselves or a first-degree relative will be excluded (since omega-3 fatty acids may be associated with anti-thrombotic effects). Similarly, concomitant use of medications with anticoagulant effects (e.g. aspirin) will be prohibited
- •Allergy to fish/seafood; 8) Currently taking omega-3 fatty acid supplements
研究组 & 干预措施
Quetiapine plus Omega
Patients will be randomized to EPA+DHA supplements (OmegaRx) at fixed dose of 3.0 g/day (EPA: 2.0 g, DHA: 1.0 g; 5 capsules/d) for 24 weeks.
干预措施: Omega (Drug)
Quetiapine plus Omega
Patients will be randomized to EPA+DHA supplements (OmegaRx) at fixed dose of 3.0 g/day (EPA: 2.0 g, DHA: 1.0 g; 5 capsules/d) for 24 weeks.
干预措施: Quetiapine fumarate (Drug)
Quetiapine plus Placebo
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
干预措施: Placebo (Drug)
Quetiapine plus Placebo
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
干预措施: Quetiapine fumarate (Drug)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: 24 weeks
Body Mass Index (BMI) is a measure of body fat calculated as weight in kilograms divided by height in meters squared (kg/m\^2). BMI Categories are: Underweight = \<18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater. Greater decreases in BMI are a better outcome.
Fasting Blood Triglycerides Levels
时间窗: 24 weeks
Triglycerides are the chemical form in which most fat exists in food as well as in the body. They're also present in blood plasma and, in association with cholesterol, form the plasma lipids. Levels are categorized as follows: Normal - Less than 150 milligrams per deciliter (mg/dL); Borderline high - 150 to 199 mg/dL; High - 200 to 499 mg/dL; Very high - 500 mg/dL or above. Greater reductions blood triglyceride levels are a better outcome.
次要结局
- Manic Symptom Severity(24 weeks)
研究者
Robert McNamara
Associate Professor of Psychiatry
University of Cincinnati