CTRI/2020/05/025260已完成2 期
Folic acid as an adjunctive therapy in patients with Bipolar Mania and its correlation with serum homocysteine levelsâ??A randomized controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
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
入选标准
- •1. Inpatients satisfying the ICD 10-DCR [1993] criteria for Bipolar affective disorder, current episode manic with psychotic symptoms with YMRS score of >20.
- •2. Age group of 18-50 years of either sex.
- •3. Drug naive patients or drug free for minimum 2 weeks on mood stabilisers/antipsychotics and 4 weeks for depot antipsychotics.
- •4. Patients started on second generation antipsychotics and any mood stabilizer except those affecting folic acid levels.
- •5. Those who give informed consent for participating in the study.
排除标准
- •1.Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine.
- •2.Significant medical or neurological illness including severe cardiovascular, hepatic, renal, [serum creatinine > 1.5 mg/dl], anaemia [Haemoglobin < 11 mg/dl], history of severe head injury or myopathy or untreated thyroid disease.
- •3.Pregnancy
- •4.BMI >30 kg/m2
- •5.Not willing to give written informed consent
- •6.Known hypersensitivity to FOLIC ACID or any of its components
- •7.Any current systemic infection/ inflammation
研究者
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