Effectiveness of metformin in reducing weight gain caused by antipsychotics
- Conditions
- Schizophrenia
- Registration Number
- SLCTR/2010/004
- Lead Sponsor
- Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
1. Patients diagnosed with schizophrenia or schizoaffective disorder according to ICD-10 research criteria
2.Age > 18 years
3.Treated with olanzapine, risperidone or clozapine
4. Gained more than 10% of the pre treatment body weight
1. Those concurrently treated with other psychotropics known to cause weight gain, (lithium carbonate, carbamazepine, sodium valproate and antidepressants)
2. Patients too ill to consent
3. Patients previously diagnosed with diabetes
4. Pregnant patients
5. Patients with impaired renal functions before enrollment (Sample size calculation is based on an expected difference in weight of Body Weight Gain of between the 2 groups, a power of 80%, and a Type I error of 5%. Sample size required in each group=64)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in total body weight [Baseline, 12 weeks and 24 weeks]<br>
- Secondary Outcome Measures
Name Time Method Body Mass Index (BMI), waist/hip ratio, fasting blood sugar, lipid profile [Baseline, 12 weeks and 24 weeks]<br>