Using Metformin to Manage Weight Gain from Antipsychotics in Adults with Intellectual Disabilities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.