Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in Triglycerides From Baseline to 16 Weeks
研究概览
简要总结
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
详细描述
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second generation) antipsychotic medication. Eligible subjects include men and women, ages 18-75, who have been taking an atypical antipsychotic for at least three months prior to enrollment. Atypical antipsychotics include: clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega), asenapine (Saphris), iloperidone (Fanapt), and lurasidone (Latuda). Eligible subjects must also have serum triglycerides >200 mg/dl or high cholesterol >250 mg/dl at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients, 18-75 years of age.
- •Serum triglycerides >200 mg/dl or high cholesterol >250 mg/dl
- •Current use of an atypical (second-generation) antipsychotic medication - including clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega) - for at least three months
排除标准
- •Current use of triglyceride or cholesterol-lowering medication other than a statin
- •Current use of omega-3 fatty acid supplement
- •Intake of fish more than twice per week
- •Currently pregnant, or breastfeeding
- •Known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies)
- •Current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg (coumadin, heparin, Plavix. etc).
- •Consumption of alcohol greater than two drinks per day or active substance abuse
- •Any medical condition that would make participation in the study unsafe, as determined by investigator
研究组 & 干预措施
open-label Lovaza (omega-3 fatty acids)
4g per day (4g once a day or 2g two times a day) for 16 weeks
干预措施: Lovaza (Drug)
结局指标
主要结局
Change in Triglycerides From Baseline to 16 Weeks
时间窗: 16 weeks
次要结局
- Change in Total Cholesterol From Baseline to 16 Weeks(16 weeks)
- Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)(16 weeks)
研究者
Marlene P. Freeman, MD
Director of Clinical Services, MGH Center for Women's Mental Health
Massachusetts General Hospital