RecruitingNot ApplicableNCT05333003

Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity

Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity for Metformin Non-responders: a Single-blind Randomized Control Trial

Sponsor

Centre for Addiction and Mental Health

Enrollment

92 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Spectrum Disorders

Summary

Rates of obesity in patients with schizophrenia-spectrum disorder (SSD)s have reached epidemic proportions, with established contributing effects of antipsychotic (AP) medications. Among agents approved for chronic weight management, glucagon-like peptide-1 receptor agonists (GLP-1RA) are associated with reductions in cardiovascular mortality, with recent FDA approval for once weekly semaglutide for this indication. This study will investigate whether semaglutide is effective in reducing body weight in overweight or obese individuals with SSDs who are on APs and do not demonstrate adequate weight loss on metformin (the first line treatment for weight loss in SSDs).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing semaglutide — the active ingredient in Ozempic and Wegovy — as a treatment for obesity in people with schizophrenia, bipolar disorder, or psychotic depression who have gained weight due to their antipsychotic medication. **You may be eligible if...** - You are 18–70 years old with a diagnosis of schizophrenia spectrum disorder, bipolar disorder, or major depression with psychotic features - You have been on a stable antipsychotic dose for at least 3 months - You have a BMI of 30 or above (or 27+ with a weight-related health condition, or 25+ if you gained weight on antipsychotics) - You have tried metformin and it either didn't work or you couldn't tolerate it **You may NOT be eligible if...** - You have type 1 or type 2 diabetes - You have serious liver or kidney disease - You have a personal or family history of thyroid cancer or a syndrome called multiple endocrine neoplasia - You have a history of pancreatitis or severe gastrointestinal disease - You are pregnant, breastfeeding, or not using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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