The goal of this clinical trial is to learn whether dapagliflozin can help manage weight gain caused by antipsychotic medications in people aged 16 years or older who are receiving antipsychotic treatment and have developed antipsychotic-induced weight gain.
The main questions it aims to answer are:
Can dapagliflozin reduce body weight as effectively and safely as metformin over the study period?
How do dapagliflozin and metformin compare in their effects on body weight, body mass index, waist circumference, blood sugar, HbA1c, lipid profile, psychiatric symptoms, quality of life, medication adherence, and side effects?
Researchers will compare dapagliflozin plus a common lifestyle program with metformin plus a common lifestyle program to see which treatment is more effective, better tolerated, and more acceptable for managing antipsychotic-induced weight gain.
Participants will:
Be randomly assigned to receive either dapagliflozin or metformin. Receive lifestyle advice, including dietary counselling, physical activity counselling, and behavioural support.
Attend clinic visits at baseline, Week 12, and Week 26 for weight, waist circumference, blood tests, medication review, and other assessments.
Receive telephone follow-up at Week 2, Week 6, and Week 18 to check medication adherence, side effects, tolerability, and lifestyle progress.
Complete questionnaires and clinical assessments related to physical activity, quality of life, psychiatric symptoms, and treatment tolerability.
Patients aged ≥16 years
Receiving stable antipsychotic treatment for ≥3 months prior to enrollment
≥7% increase in body weight from baseline following initiation of antipsychotic treatment, or
BMI >25 kg/m² with clinically established antipsychotic-associated weight gain
Diabetes mellitus
Diagnosed patients of polycystic ovarian syndrome (PCOS)
Renal impairment defined as estimated glomerular filtration rate (eGFR <45 mL/min/1.73 m²)
Significant hepatic disease or other serious or unstable medical conditions that, in the opinion of the investigator, would make participation unsafe
Parallel
Dapagliflozin
DrugDapagliflozin will be administered orally at a dose of 10 mg once daily. Treatment will continue for 26 weeks. Participants will be monitored for adherence, tolerability, and adverse events, including genitourinary symptoms, dehydration, sick-day events, and symptoms suggestive of ketoacidosis.
Metformin
DrugMetformin will be administered orally. Participants will start with 500 mg twice daily, taken with meals, and will be titrated to 1000 mg twice daily by the second week as tolerated. Slower titration may be used if gastrointestinal side effects occur. Treatment will continue for the study period, with the primary endpoint assessed after 26 weeks at the maximum tolerated dose.
Common Lifestyle Program
Other interventionAll participants will receive a standardized common lifestyle program. This will include dietary counselling, physical activity counselling, and behavioural support delivered at baseline and reinforced during scheduled in-person visits and telephone follow-up. Physical activity will be assessed using the International Physical Activity Questionnaire.
Change in Body Weight
Change in body weight from baseline to the primary endpoint. Body weight will be measured using standardized procedures and compared between the dapagliflozin plus common lifestyle program arm and the metformin plus common lifestyle program arm.
Change in Body Mass Index (BMI)
Change in BMI (kg/m²) from baseline to week 26 to evaluate overall body composition changes associated with each intervention.
Change in Waist Circumference
Change in waist circumference (measured at the midpoint between the lowest rib and iliac crest) from baseline to week 26, assessing central fat distribution.
Change in Fasting Plasma Glucose
Difference in fasting plasma glucose levels from baseline to week 26, reflecting glucose metabolism and glycemic control.
Change in Glycated Hemoglobin (HbA1c)
Change in HbA1c (%) from baseline to week 26, assessing long-term glucose regulation.
Physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Self-reported physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Physical activity will be measured to describe participant activity levels and to support adjustment for physical activity as a potential confounding variable in analyses of body weight and metabolic outcomes.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: