Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability (METIDD)
Intellectual Disability, Developmental Disability, Obesity
About this trial
This is an interventional treatment trial for Intellectual Disability focused on measuring Intellectual Disability, Developmental Disability, Obesity, Metformin
Eligibility Criteria
Inclusion Criteria: Stable outpatients Age 18-65 years Diagnosed with 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. Females of child-bearing age must be on one of the following regular contraceptives: Agree to abstain from sex for the duration of the trial or A barrier method of a diaphragm with spermicide and/or Latex condom or 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 An intrauterine device, or 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Metformin (Oral)
Placebo
50 participants will be administered oral metformin titrated to a maximum dose of 2000mg/day for 24 weeks.
50 participants will be administered an identical oral placebo for 24 weeks.