Topiramate for Schizophrenia

Recruiting in Palo Alto (17 mi)

Overseen byMargaret Hahn, PhD, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre for Addiction and Mental Health

Stay on Your Current Meds

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals aged 17-59 with schizophrenia or schizoaffective disorder, who are overweight and have been on clozapine treatment. They must not have major organ dysfunction, uncontrolled diabetes, recent major medical events, a history of renal stones or glaucoma, acute suicidal risk, or changes in certain medications recently.

Inclusion Criteria

I have been on Clozapine for 12 weeks or more at a high dose or with high blood levels.

BMI greater than or equal to 25

I am between 17 and 59 years old.

+2 more

Exclusion Criteria

I have a history of glaucoma.

You are currently at risk of harming yourself or having thoughts of suicide.

I have liver or kidney problems.

+12 more

Participant Groups

The study tests if Topiramate helps reduce weight and improve mental health symptoms in patients with severe schizophrenia taking clozapine. Participants will either receive Topiramate or a placebo to see which is more effective.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TopiramateExperimental Treatment1 Intervention

Topiramate will be dispensed on a biweekly basis, and pill counts conducted at each visit.

Group II: PlaceboPlacebo Group1 Intervention

Placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.