NCT02808533Active, not recruiting
Topiramate and Schizophrenia: Effects on Weight and Psychopathology
Topiramate in Treatment Refractory Psychotic Illness: Effects on Weight Gain and Psychopathology
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
Clozapine is the sole AP agent with superiority in treatment refractory schizophrenia, but it also is associated with the greatest risk of weight gain and other metabolic abnormalities. Topiramate, an anticonvulsant agent, possesses a weight-reducing effect. Furthermore, some studies have suggested that Topiramate may be associated with improvements in psychopathology in treatment refractory schizophrenia. Here the investigators propose to determine the role of topiramate for augmentation purposes (psychopathology) and as an adjunctive pharmacological intervention for weight loss in overweight/obese individuals with Ultra-Treatment Resistant Schizophrenia or Schizoaffective disorder taking clozapine.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 15 Jun 2016
- Start date
- 1 May 2016
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Schizophrenia
- NCT number
- NCT02808533
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 May 2016 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Use of Carbonic Anhydrase Inhibitor
Other illness
- Alcohol use disorder
- History of renal stones
- History of glaucoma
Lab values
- Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematological, or pulmonary disease.
- HbA1c \> 9%, or symptomatic hyperglycemia with metabolic decompensation
Age
- Females of child bearing age not on a regular contraceptive, females who are nursing
Other
- Patients with liver, or renal dysfunction
- Acute Suicidal risk
Who the study is looking for
- 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
Age in the registry: 17 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.