Topiramate and Schizophrenia: Effects on Weight and Psychopathology (NCT02808533) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Topiramate and Schizophrenia: Effects on Weight and Psychopathology
Canada50 participantsStarted 2016-05
Plain-language summary
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.
Who can participate
Age range
17 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.