Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called metformin to help manage weight gain in adults with intellectual and developmental disabilities (IDD) who are taking antipsychotic medications. Many people with IDD struggle with obesity, which can lead to serious health problems. This study is the first of its kind to look at how effective metformin can be for this specific group, as they have often been left out of previous research. The goal is to find a safe and effective way to help these individuals manage their weight and improve their overall health.

To be eligible for the trial, participants must be adults aged 18 to 65 who have been diagnosed with IDD and are currently taking a stable dose of an antipsychotic medication. They also need to have a body mass index (BMI) of 30 or higher, or 27 or higher with a related health issue like high blood pressure or diabetes. Participants can expect to take metformin for a set period and will be monitored closely for any effects. It's important to note that certain individuals, such as those who are pregnant or have certain medical conditions, cannot participate in the trial. This study aims to provide valuable information that could lead to better treatment options for a population that has significant healthcare needs.

Gender

ALL

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:
• • 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