Topiramate and Schizophrenia: Effects on Weight and Psychopathology

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborator: Ontario Ministry of Health and Long Term Care
• Treatments: Topiramate

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