IRCT138712231764N1已完成2 期
Effect of omega-3 fatty acids on the components of metabolic syndrome in schizophrenic, bipolar and schizoaffective patients taking olanzapine plus sodium valproate or olanzapine plus lithium.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 60 years（—）
- 性别
- All
入选标准
- •psychiatric patients taking olanzapine plus sodium valproate or olanzapine plus lithium with clinical diagnosis of schizophrenia, bipolar mood disorder, schizoaffective disorder, ages between 18-60 yrs.
- •Exclusion criteria:
- •1- Previous treatment with study drugs (olanzapine, sodium valproate, lithium) during the three months prior to trial initiation/participation,
- •2- Having a significant active medical problem or abnormal lab tests before initiation of trial including:
- •Liver function tests= 3 normal ,
- •Thyroid stimulating hormone > 4.2 m.I.U/L,
- •GFR< 60 ml/min,
- •FBS> 125 mg/dl,
- •TG = 500 mg/dl ,
- •TG between 200-500 and Non-HDL cholesterol greater than or equal to 30+ target LDL: in cases of TG between 200-500, first Non-HDL cholesterol is calculated. Then the goal LDL of the patient is assessed according to NCEP ATP III LDL goals. Participants with TG between 200-500 are excluded if their Non-HDL cholesterol is greater than or equal to 30 + target LDL.
- •3- Pregnancy and lactation
- •4-Recent (within 4 weeks) consumption of omega 3 fatty acids
- •5-BMI = 30
- •6-Contraindications for the study drugs
- •7-Patients or their family refusal to participation
- •8-Taking Drugs much affecting study parameters.
排除标准
- 未提供
研究者
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