A clinical trial to study the effects of metformin in prevention of olanzapine induced weight gain, type 2 diabetes mellitus and lipid abnormalities in patients with schizophrenia.
Phase 3
- Conditions
- Health Condition 1: null- schizophrenia, obesity, hyperglycemia, insulin resistance and hypertriglyceridemia
- Registration Number
- CTRI/2013/05/003685
- Lead Sponsor
- Dr Urmila Anil Kagal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients of either sex aged between 18 and 65 years suffering from first episode schizophrenia as diagnosed by the Diagnostic and Statistical Manual of Mental disorders IV (DSM IV) criteria.
Exclusion Criteria
a. Patients with pre-existing obesity. (Body mass index >30kg/m2 and/or waist circumference >= 90cm and >=80cm in males and females respectively).
b. Patients with a known diagnosis of type 1 or type 2 diabetes mellitus.
c. Patients suffering from anorexia nervosa, bulimia nervosa or neoplastic disease.
d. Patients with a history of alcohol dependence.
e. Patients suffering from any major endocrine disorder.
f. Patient on treatment for any major medical or surgical illness.
g. Pregnant and lactating women.
h. Non complying patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method