Metformin for control of weight gain related to sodium valproate administration in adults
- Conditions
- Association of metformin and control of weight gain related to sodium valproate administration in adults.Unspecified mental disorder
- Registration Number
- IRCT2017071322991N8
- Lead Sponsor
- Vice chancellor for research of Babol University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
age 18 to 65 years; under medication with sodium valproate for at least one month; self-reported weight gain more than three kilogram after sodium valproate administration; filling and assignment the informed consent form
Exclusion criteria: diabetes in the patient; endocrine disorder in which the patient is treated with steroids; administration other psychotropic drugs except sodium valproate; suspect to polycystic ovarian disease in the patient; mental retardation or other severe physical or mental disorders which inhibit the cooperation of the patient in the research; pregnancy and breast-feeding; impairment of renal or hepatic function (creatinine or liver enzymes more than 150 percent higher than normal value); alcohol, narcotic and psychotropic drugs consumption
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight of the patient. Timepoint: 4th, 8th and 12th weeks after intervention. Method of measurement: Digital scale.;Body Mass Index. Timepoint: 4th, 8th and 12th weeks after intervention. Method of measurement: Weight (kilogram) divided by squared height (meter).
- Secondary Outcome Measures
Name Time Method Drug side-effects. Timepoint: 4th, 8th and 12th weeks after intervention. Method of measurement: Patient visit.;Quality of life. Timepoint: 12 weeks after intervention. Method of measurement: SF-36 quality of life questionnaire.