Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health

Criteria

Inclusion Criteria:

• Stable outpatients aged 18-55 years, diagnosed with SCZ, or schizoaffective disorder

• On maintenance treatment (> 9 months) with an AP (stable dose for ≥3 months).

• BMI must be ≥30 kg/m2, or ≥27 kg/m2 with the presence of at least one weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose.

• History of failure to lose ≥5% body weight over a three month period on the highest tolerated trial of metformin

Exclusion Criteria:

• Patients with severe substance disorder other than tobacco or caffeine use disorder

• Liver, or renal dysfunction

• A positive drug urine screen

• Females of child-bearing age not on a regular contraceptive, or nursing or with a positive pregnancy test

• Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease

• History of reactive hypoglycaemia

• Treatment within 3 months, or failure to tolerate GLP-1RA

• Type 1 Diabetes (T1D) or history of Type 2 Diabetes (T2D), diagnosis of T2D on OGTT screen, HbA1c > 6.5%

• Medications with significant renal impact or weight-lowering agents

• Major medical or surgical event within the preceding 3 months

• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome

• History of pancreatitis or elevated amylase on screen

• History of severe gastrointestinal disease, (i.e. gastroparesis)

• Acute suicidal risk

• Hypothyroidism or being treated with levothyroxine

• Treatment with warfarin or coumarin derivatives

• History of metabolic acidosis or lactic acidosis

• History of heart rhythm disturbances, conduction system abnormalities, or evidence of abnormalities on screening ECG.

• Any condition that interferes with the safe acquisition of MRI data such as metal implants, pacemakers, aneurysm clips, cochlear implants (only for the MRI component; can participate in the remainder of the trial)