Bipolar disorder. Bipolar disorder
Conditions
Interventions
Intervention 1: Intervention group: Group 1: Metformin Group receive metformin starting at a dose of 500 mg per day, titrated gradually up to a maximum dose of 1500 mg per day over two weeks. Interve
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: age above 20 . diagnosis of bipolar disorder based on the statistical diagnostic manual of mental disorders , 5th edition ( DSM- 5 ) criteria . body mass index is more than 27 kg / m2 and waist circumference more than 90 cm in men and 80 cm in women . non - diabetic state and normal blood pressure . fixed record of current drug usage ( sodium valproate ) for at least 6 months . lack of record of weight loss over 5 % in 3 months before hiring
Exclusion criteria
Exclusion criteria: any significant side-effects of metformin and Topiramate exposure to the acute phase of the disease . new involvement in drug related disorders no compliance with drug engaging in a particular diet or special exerciseprogram to reduce weight . new medical disease new use of other drugs such as weight loss or drugs with metformin or Topiramate .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight (in kg). Timepoint: in the week 4 , 8 and 12. Method of measurement: Data for weights will first be recorded in pre-prepared data sheets (case report forms) and then entered into an Excel file. Statistical analysis will be performed using SPSS version 26. The 3-month (approximately 12-week) duration for weight response follow-up is supported by robust scientific evidence, as clinical trials have demonstrated that measurable effects of metformin and topiramate on weight and related indices are observable within this timeframe. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohsen Heydari Mokarar
Karaj University of Medical Sciences
Outcome results
None listed