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NOT YET RECRUITING

NCT07342764

PHASE4

Dapagliflozin Versus Metformin for the Management of Antipsychotic-Induced Weight Gain: A Pragmatic Pilot Randomized Controlled Trial

Sponsor: Sultan Qaboos University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

16 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-09

Completion Date

2028-12

Last Updated

2026-06-10

Healthy Volunteers

Conditions

Antipsychotic-induced Weight Gain (AIWG)Antipsychotic-induced Weight Gain

Interventions

DRUG

Dapagliflozin

Dapagliflozin 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.

DRUG

Metformin

Metformin 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.

OTHER

Common Lifestyle Program

All 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.

Inclusion criteria: * Patients aged ≥16 years * Diagnosis according to DSM-5 criteria, including: Schizophrenia spectrum and other psychotic disorders, as summarized in the DSM-5 chapter Schizophrenia Spectrum and Other Psychotic Disorders, excluding: Substance/medication-induced psychotic disorder Psychotic disorder due to another medical condition Catatonia associated with another mental disorder Catatonic disorder due to another medical condition Unspecified catatonia Bipolar and related disorders, as summarized in the DSM-5 chapter Bipolar and Related Disorders Depressive disorders, as summarized in the DSM-5 chapter Depressive Disorders Obsessive-compulsive and related disorders, as summarized in the DSM-5 chapter Obsessive-Compulsive and Related Disorders Other psychiatric conditions for which antipsychotic treatment is clinically indicated, as judged by the investigator Other conditions where antipsychotics are indicated * Receiving stable antipsychotic treatment for ≥3 months prior to enrollment * Evidence of antipsychotic-induced weight gain (AiWG), defined as: 1. ≥7% increase in body weight from baseline following initiation of antipsychotic treatment, or 2. BMI \>25 kg/m² with clinically established antipsychotic-associated weight gain * Able to understand and comply with study procedures, as judged by the investigator * Able to provide written informed consent. For participants aged 16-17 years, assent and/or guardian consent will be obtained according to local ethics committee requirements. Exclusion criteria: * 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 * Pregnant or breastfeeding females * Current use of metformin, dapagliflozin, or another sodium-glucose cotransporter 2 inhibitor. * Use of weight-loss medications or participation in structured weight-loss programs within the past 3 months * Recurrent genitourinary infections (if dapagliflozin is used) * Use of non-antipsychotic medications known to cause clinically significant weight gain, including but not limited to selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), mirtazapine, tricyclic antidepressants, valproate, lithium, corticosteroids, sedating antihistamines, or other medications as judged by the investigator * Unstable psychiatric condition or active substance use disorder that may impair the ability to adhere to study procedures, as judged by the investigator

Locations (1)

SQU

Muscat, Oman