Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT02808533
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
59 Years
Study:
NCT02808533
Study Brief:
Protocol Section:
NCT02808533