Clinical trial to study the efficacy of folic acid in patients with Bipolar Mania and correlating it with serum homocysteine levels
- Conditions
- Health Condition 1: F312- Bipolar disorder, current episodemanic severe with psychotic features
- Registration Number
- CTRI/2020/05/025260
- Lead Sponsor
- Central Institute of Psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of folic acid on the levels of homocysteineTimepoint: Baseline, 2 weeks and 6 weeks
- Secondary Outcome Measures
Name Time Method To study the correlation of changes in YMRS, BPRS & CGI with socio-demographic, clinical and laboratory parameters in patients receiving folic acid and those not receiving folic acid.Timepoint: Baseline, 2 weeks and 6 weeks