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

Study acronym: METIDD
StatusRecruiting
PhasePhase 4
Started2023-02-28
View on ClinicalTrials.gov ↗

Amendment history

2026-03-26
minor
Study Status, Oversight v4
Primary completion date2025-12-01→2027-03-01
Completion date2026-12-01→2027-03-01
2025-07-31
minor
Study Status, Oversight, Eligibility v3
Eligibility criteria+88 characters
Inclusion Criteria: Stable outpatients Age 1816-65 years Diagnosed with an IDD On maintenance treatment with an antipsychotic (stable dose for ≥3 months). BMI must be ≥30 kg/m2, orOR ≥27 kg/m2 with at least one weight-related comorbidity (tre [...] daemia, 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 followi [...]
2024-08-19
minor
Study Status v2
Re-verified, no change to tracked fields
2024-01-11
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2023-02-15
minor
Original filing
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 negatively impact psychosocial outcomes, in a hugely underserviced population.This is the the first RCT (randomized control trial) to examine the efficacy of metformin in overweight or obese adults with IDD who have experienced antipsychotic-induced weight gain. By generating efficacy data for a very accessible and scalable intervention, allows for guideline and implementation strategies to address a recalcitrant health problem.
Trial Details
NCT Number NCT05744479
Lead Sponsor Centre for Addiction and Mental Health
Conditions Intellectual Disability, Developmental Disability, Obesity
Enrollment 100 participants
Start Date 2023-02-28
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-31