Actively Recruiting
Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability
Led by Centre for Addiction and Mental Health · Updated on 2026-03-31
100
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable outpatients
- Age 16-65 years
- Diagnosed with an intellectual or developmental disability
- On maintenance treatment with an antipsychotic at a stable dose for at least 3 months
- Body mass index (BMI) of 30 kg/m2 or higher, OR BMI of 27 kg/m2 or higher with at least one weight-related health condition such as hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose, OR BMI of 25 kg/m2 or higher with more than 5% weight gain associated with antipsychotic use
- Females of child-bearing age must agree to abstain from sex during the trial or use one of the following contraceptive methods: barrier method with spermicide and/or latex condom, oral contraceptive, implantable or injectable contraceptive used for at least 6 months before and during the study, intrauterine device, or partner with vasectomy at least 3 months before study start
You will not qualify if you...
- Females who are pregnant, nursing, or have a positive pregnancy test
- Clinical or laboratory evidence of uncontrolled cardiovascular, endocrine, blood, liver, kidney, or lung disease
- Previous treatment with metformin that was ineffective or not tolerated
- History or diagnosis of type 1 or type 2 diabetes, or HbA1c above 6.5%
- History of metabolic or lactic acidosis
- Treatment with weight-lowering medications
- Use of medications with significant impact on kidney function
- Major medical or surgical event within the past 3 months
- Acute risk of suicide
- Moderate to severe substance use disorder except for caffeine or nicotine use disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H3
Actively Recruiting
Research Team
M
Mahavir Agarwal, MD, PhD
CONTACT
M
Maria Papoulias
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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