Overview

Comparative Effectiveness of Dapagliflozin, Metformin, and Lifestyle Modification for Antipsychotic-Induced Weight Gain: An Open-Label Pragmatic Trial

Status:
NOT_YET_RECRUITING

Trial end date:
2028-12-01

Target enrollment:

Participant gender:

Summary

Clinical trial: The goal of this clinical trial is to learn if dapagliflozin can help reduce weight gain caused by antipsychotic medications in people with schizophrenia and related disorders. It will also assess the safety of dapagliflozin. * The main questions it aims to answer are: * Does dapagliflozin lower body weight compared to metformin or lifestyle changes alone? * Does it improve blood sugar, cholesterol, and overall health? * Researchers will compare three groups: * Dapagliflozin plus lifestyle changes * Metformin plus lifestyle changes * Lifestyle changes alone * Participants will: * Take the assigned medication daily for 26 weeks (or follow lifestyle guidance only) * Attend clinic visits at weeks 0, 4, 12, and 26 for measurements and blood tests * Receive phone calls for follow-up and side effect checks

Phase:

PHASE4

Details

Lead Sponsor:

Sultan Qaboos University

Treatments:

dapagliflozin
Metformin