Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability
Status:
Not yet recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
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.