Using Topiramate to Manage Weight and Symptoms in Schizophrenia
Official title: Topiramate in Treatment Refractory Psychotic Illness: Effects on Weight Gain and Psychopathology
Run by Centre for Addiction and Mental Health · NCT02808533 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if the medication Topiramate can help people with treatment-resistant schizophrenia or schizoaffective disorder manage their weight and improve their mental health while they are on clozapine.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 17 Years to 59 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT02808533 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 17-59 with schizophrenia or schizoaffective disorder who have been on clozapine for at least 12 weeks and have a BMI of 25 or greater.
✕Probably not a fit
Patients with alcohol use disorder, significant liver or renal dysfunction, or those who have previously not tolerated Topiramate may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of Topiramate, an anticonvulsant medication, on weight and psychopathology in individuals with treatment-resistant schizophrenia or schizoaffective disorder who are currently taking clozapine. The research aims to determine whether Topiramate can serve as an effective adjunctive treatment to mitigate weight gain and improve mental health symptoms in this patient population. Participants will be randomly assigned to receive either Topiramate or a placebo, and various health metrics will be monitored throughout the study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that helps manage weight and improve mental health outcomes for patients with treatment-resistant schizophrenia.
How similar studies have gone: While there is some evidence supporting the use of Topiramate in treatment-resistant schizophrenia, this specific approach is relatively novel and has not been extensively tested in controlled trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Schizophrenia or Schizoaffective disorder * 17-59 years of age * Clozapine treatment for at least 12 weeks at a dose 350 mg/d or greater and/or plasma clozapine levels of 300 ng/mL or greater * CGI must be 4 or higher and/or GAF \< 50 * BMI greater than or equal to 25 Exclusion Criteria: * Alcohol use disorder * Patients with liver, or renal dysfunction * Females of child bearing age not on a regular contraceptive, females who are nursing * Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematological, or pulmonary disease. * HbA1c \> 9%, or symptomatic hyperglycemia with metabolic decompensation * Prior lack of efficacy or tolerability of Topiramate * Addition of new hypoglycemic or lipid lowering medication within 2 months of starting study * Patients treated with Valproic Acid * Patients treated with hydrochlorothiazide * Switch in antipsychotic medications within 3 months of study entry * Major medical or surgical event within the preceding 3 months * History of renal stones * Use of Carbonic Anhydrase Inhibitor * History of glaucoma * Acute Suicidal risk
Where it's running
-
Center for Addiction and Mental Health
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Margaret Hahn, PhD, MD — Centre for Addiction and Mental Health
- Study coordinator: Margaret Hahn, PhD, MD
- Email: margaret.hahn@camh.ca
- Phone: 416-535-8501
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.