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Clinical trial to study the efficacy of folic acid in patients with Bipolar Mania and correlating it with serum homocysteine levels

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025260
Enrollment
60
Registered
2020-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F312- Bipolar disorder, current episodemanic severe with psychotic features

Interventions

Intervention1: Folic acid: Dose- 5 mg Frequency- Once daily Route- Oral Duration- 6 weeks Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Sponsors

Central Institute of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

MeasureTime frame
Effect of folic acid on the levels of homocysteineTimepoint: Baseline, 2 weeks and 6 weeks

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDR PRANJAL DEY

Department of Psychiatry

pranjalde80@gmail.com0651-2451113

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026