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Study identifier: NCT05744479 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Intellectual Disability · Developmental Disability · Obesity  ·  Sponsor: Centre for Addiction and Mental Health

PhasePhase 4
Planned participants100
Who can joinAll sexes, 16 Years to 65 Years
Healthy volunteersNo

About this study

People with IDD (intellectual and developmental disability) have very high rates of obesity and die prematurely from cardiometabolic disease. While antipsychotics contribute to this problem, their use is necessary and appropriate in a significant subgroup of individuals with IDD. Exercise and diet interventions have limitations and may not be sufficient, requiring effective adjunctive pharmacological approaches to target obesity and related comorbidities in IDD. However, persons with IDD treated with antipsychotics are systematically excluded from clinical trials hindering development of evidence to help guide safe and effective treatment of these comorbidities. Moreover, evidence from other disorders cannot be extrapolated to IDD given inherent biological differences between disorders. This trial will address the identified gaps, which extend beyond cardiovascular morbidity and negatively impact psychosocial outcomes, in a hugely underserviced population.This is the the first RCT (randomized control trial) to examine the efficacy of metformin in overweight or obese adults with IDD who have experienced antipsychotic-induced weight gain. By generating efficacy data for a very accessible and scalable intervention, allows for guideline and implementation strategies to address a recalcitrant health problem.

This description comes directly from the study's public registry record.

Talk to the study team

Mahavir Agarwal, MD, PhD  ·  4165358501  ·  mahavir.agarwal@camh.ca

Maria Papoulias  ·  4165358501  ·  maria.papoulias@camh.ca

Always discuss trial participation with your own doctor first.

Locations (1)

Centre for Addiction and Mental HealthToronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT05744479