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