Folic acid as an adjunctive therapy in patients with Bipolar Mania and its correlation with serum homocysteine levelsâ??A randomized controlled clinical trial

Central Institute of Psychiatry0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•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.

•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

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