Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2026

Conditions
Intellectual DisabilityDevelopmental DisabilityObesity
Interventions
DRUG

Metformin

Metformin oral, 2000mg/day, for 24 weeks.

DRUG

Placebo

Oral placebo for 24 weeks

BEHAVIORAL

Lifestyle Intervention

Participants from both groups will meet a dietician and a diabetes educator at the study start to obtain advice regarding healthy diet, portion size, and meal planning to improve physical health. All participants will be invited to monthly group meetings to learn skills which will help them in a variety of wellness areas such as physical exercises and diet. Attendance in these sessions will be encouraged but not mandatory, and attendance will be recorded. Fidelity with these interventions will be captured using diet and physical activity questionnaires at RCT start, midpoint and end, and end of open label phase.

Trial Locations (1)

M6J1H3

RECRUITING

Centre for Addiction and Mental Health, Toronto

All Listed Sponsors
lead

Centre for Addiction and Mental Health

OTHER