Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability (NCT05744479)
Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability: A Double-Blind Randomized Control Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Centre for Addiction and Mental Health — Toronto, Ontario
Age range: 16 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Centre for Addiction and Mental Health — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 535-8501
Email: mahavir.agarwal@camh.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Intellectual Disability
- Improving the Health of Parents and Their Adolescent and Transition-age Youth With Intellectual and Developmental Disabilities — Carrboro, North Carolina
- Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers — New Hyde Park, New York
- Characterization of Nociception Phenotype in Individuals With Intellectual Disability — Bethesda, Maryland
- Mental Health Crises in Youth With IDDs — San Diego, California
- Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities — Kansas City, Kansas
Explore by condition: All Intellectual Disability clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.