Using Metformin to Manage Weight Gain from Antipsychotics in Adults with Intellectual Disabilities
Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability: A Double-Blind Randomized Control Trial
This study tests if Metformin can help adults with intellectual disabilities who are gaining weight from antipsychotic medications lose weight and improve their health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05744479 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Metformin as a treatment for obesity in adults with intellectual and developmental disabilities (IDD) who are also receiving antipsychotic medications. Given the high rates of obesity and related health issues in this population, the study aims to provide a pharmacological solution to complement lifestyle interventions. Participants will be randomly assigned to receive either Metformin or a placebo, alongside lifestyle modifications, to assess changes in weight and related health outcomes. This trial addresses a significant gap in research, as individuals with IDD have been largely excluded from previous studies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a diagnosis of intellectual and developmental disabilities who are stable outpatients on antipsychotic medication and have a BMI of 30 or higher.
Not a fit: Patients who are currently pregnant, nursing, or have a positive pregnancy test will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for managing weight gain in individuals with IDD who require antipsychotic medications.
How similar studies have performed: While there is limited research specifically targeting this population, similar pharmacological approaches have shown promise in other groups, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stable outpatients * Age 16-65 years * Diagnosed with an IDD * On maintenance treatment with an antipsychotic (stable dose for ≥3 months). * BMI must be ≥30 kg/m2, OR ≥27 kg/m2 with at least one weight-related comorbidity (treated or untreated) such as: hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose, OR \>=25 for individuals who have gained \> 5% body weight in association with AP use. * Females of child-bearing age must be on one of the following regular contraceptives: 1. Agree to abstain from sex for the duration of the trial or 2. A barrier method of a diaphragm with spermicide and/or Latex condom or 3. An oral contraceptive agent, implantable contraceptive or an injectable contraceptive for at least six months prior to entering the study and will continue its use throughout the study, or 4. An intrauterine device, or 5. Partner has had a vasectomy at least 3 months prior to study start Exclusion Criteria: * Females who are nursing, currently pregnant, or have a positive pregnancy test * Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, hepatic, renal, or pulmonary disease * Previous treatment and lack of efficacy or tolerability with metformin * History or diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (TD2) or fasting blood work, HbA1c \> 6.5% * History of metabolic acidosis or lactic acidosis * Treatment with weight-lowering agents * Medications with significant renal impact * Major medical or surgical event in the preceding 3 months * Acute suicidal risk. * Moderate to severe substance use disorder, other than caffein or nicotine use disorder
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Mahavir Agarwal, MD, PhD
- Email: mahavir.agarwal@camh.ca
- Phone: 4165358501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.