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โ† Trials
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Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability

RecruitingPhase 4Ages 16 Years - 65 YearsAllCentre for Addiction and Mental Health
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In plain words

What the trial is, and whether it could suit you

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 negative

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Stable outpatients * Age 16-65 years * Diagnosed with an IDD * On maintenance treatment with an antipsychotic (stable dose for โ‰ฅ3 months). * BMI must be โ‰ฅ30 kg/m2, OR โ‰ฅ27 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
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What it tests

  • Metformin
  • Placebo
  • Lifestyle Intervention
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Where

1 site
Centre for Addiction and Mental Health
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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