Using semaglutide to help manage weight in patients with schizophrenia and obesity
Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity for Metformin Non-responders: a Single-blind Randomized Control Trial
This study is testing if the medication semaglutide can help people with schizophrenia and obesity lose weight when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05333003 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of semaglutide, a glucagon-like peptide-1 receptor agonist, in reducing body weight among individuals with schizophrenia spectrum disorders who are overweight or obese and have not responded adequately to metformin. Participants will be stable outpatients or inpatients aged 18-70 years, diagnosed with schizophrenia spectrum disorder or related conditions, and on maintenance treatment with antipsychotic medications. The study will assess changes in body weight, glucose metabolism, cardiovascular risk factors, psychopathology, cognition, and lifestyle factors over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are stable outpatients or inpatients aged 18-70 years with schizophrenia spectrum disorders or related conditions, who are overweight or obese and have not lost sufficient weight on metformin.
Not a fit: Patients with severe substance use disorders other than tobacco or caffeine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for weight management in patients with schizophrenia spectrum disorders, potentially improving their overall health and quality of life.
How similar studies have performed: While the use of GLP-1 receptor agonists in this specific population is relatively novel, preliminary evidence suggests potential benefits, indicating that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stable outpatients or inpatients aged 18-70 years, diagnosed with schizophrenia spectrum disorder, or major depressive disorder with psychotic features, or bipolar disorder (does not need to have psychotic features) * On maintenance treatment 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, OR BMI ≥25 with individual having gained \>5% bodyweight in association with AP treatment * History of either failure to tolerate metformin or failure to lose ≥5% body weight over at least 16 weeks on the highest tolerated trial of metformin, and who are not currently being treated with metformin (minimum of 1 week metformin-free prior to study entry) Exclusion Criteria: * Patients with severe substance disorder other than tobacco or caffeine use disorder; only severe substance use disorder is exclusionary for cannabis use * Liver, or renal dysfunction * A positive drug urine screen other than cannabis as per PI discretion * Sexually active 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 current diagnosis of Type 2 Diabetes (T2D), diagnosis of T2D on OGTT screen, or HbA1c \> 6.5% * Use of Health Canada approved weight-lowering agents, warfarin, coumarin derivatives, or medication with significant renal impact * 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 * Uncompensated thyroid disorder * History of heart rhythm disturbances, conduction system abnormalities, or evidence of clinically relevant 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) * History of gallstones with intact gallbladder or those at increased risk of gallbladder complications (with intact gallbladder)
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Margaret Hahn, MD, PhD — Centre for Addiction and Mental Health
- Study coordinator: Margaret Hahn, MD, PhD
- Email: margaret.hahn@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.