Topiramate for Schizophrenia

Palo Alto (17 mi)

Overseen byMargaret Hahn, PhD, MD

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

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.

I am between 17 and 59 years old.

I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

I have a history of glaucoma.

I have liver or kidney problems.

I have had kidney stones in the past.

I am of childbearing age and not using contraception, or I am nursing.

I have a serious heart, blood, lung, or hormone-related condition that is not under control.

I am currently taking hydrochlorothiazide.

My HbA1c level is above 9%, or I have severe symptoms of high blood sugar.

Topiramate was ineffective or caused side effects for me.

I have not had any major medical or surgical events in the last 3 months.

I am taking medication that reduces fluid production in my body.

I am currently being treated with Valproic Acid.

Treatment Details

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.