Therapeutic effects of N-AcetylCysteine in Bipolar Mania as assessed by Serum Glutathione levels
- Conditions
- Health Condition 1: F312- Bipolar disorder, current episodemanic severe with psychotic features
- Registration Number
- CTRI/2023/08/056207
- Lead Sponsor
- Central Institute of Psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 < 11 mg/dL], history of severe head injury or myopathy or untreated thyroid disease.
3. Pregnancy.
4. BMI > 30 kg/m2.
5. Known hypersensitivity to N-AcetylCysteine or any of its components.
6. Any current systemic infection/inflammation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in serum glutathione levels after treatment with NAcetylCysteineTimepoint: Change in serum glutathione levels after treatment with NAcetylCysteine at baseline 2 weeks & 6 weeks