Dapagliflozin Versus Metformin for the Management of Antipsychotic-Induced Weight Gain: A Pragmatic Pilot Randomized Controlled Trial
Other study identifiers
Sponsor study identifier
interventional
110
1 country
1
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- not yet recruiting
- Estimated enrollment
- 110 participants
- Study completion date
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
January 6, 2026
Actual (reported)First Posted
January 15, 2026
Actual (reported)Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- June 10, 2026
- Status Verified
- June 2026
- Last Update Submitted
- June 6, 2026