Health Condition 1: F312- Bipolar disorder, current episodemanic severe with psychotic features
Conditions
Interventions
Intervention1: N-AcetylCysteine in Bipolar Mania with psychotic symptoms: N-AcetylCysteine will be given for total duration of 6 weeks, 2 g/day will be given for first 4 weeks followed by 4 g/day for
Sponsors
Central Institute of Psychiatry
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inpatients satisfying the ICD 11- DCR criteria for Bipolar type I disorder , current episode manic, with psychotic symptoms. 2. YMRS score > 20. 3. Age group of 18-50 years of either sex. 4. Drug â?? naïve patients or drug-free for a minimum of 2 weeks on mood stabilisers/antipsychotics and 6 weeks for depot antipsychotics. 5. Patients started on second-generation antipsychotics and mood stabiliser. 6. 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], anemia [Hemoglobin 3. Pregnancy. 4. BMI > 30 kg/m2. 5. Known hypersensitivity to N-AcetylCysteine or any of its components. 6. Any current systemic infection/inflammation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement on YMRS BPRS CGIS scores in patients of Bipolar Mania with NAcetylCysteine as an adjuvantTimepoint: Improvement on YMRS BPRS CGIS scores in patients of Bipolar Mania with NAcetylCysteine as an adjuvant at baseline 2 weeks & 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum glutathione levels after treatment with NAcetylCysteineTimepoint: Change in serum glutathione levels after treatment with NAcetylCysteine at baseline 2 weeks & 6 weeks | — |
Countries
India
Contacts
Public ContactDr Anjanik Kumar Rajan
Central Institute of Psychiatry
Outcome results
None listed