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Topiramate for Schizophrenia

N/A
Recruiting
Led By Margaret Hahn, PhD, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
17-59 years of age
Must not have
History of glaucoma
Patients with liver or renal dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial will study whether topiramate can help improve symptoms and cause weight loss in people with schizophrenia who haven't responded to other treatments and are taking clozapine.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Topiramate may cause side effects like tingling sensations, taste alterations, weight loss, confusion, drowsiness and possibly an increased risk of kidney stones and eye problems (glaucoma).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on Clozapine for 12 weeks or more at a high dose or with high blood levels.
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I am between 17 and 59 years old.
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I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of glaucoma.
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I have liver or kidney problems.
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I have had kidney stones in the past.
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I am of childbearing age and not using contraception, or I am nursing.
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I have a serious heart, blood, lung, or hormone-related condition that is not under control.
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I am currently taking hydrochlorothiazide.
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My HbA1c level is above 9%, or I have severe symptoms of high blood sugar.
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Topiramate was ineffective or caused side effects for me.
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I have not had any major medical or surgical events in the last 3 months.
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I am taking medication that reduces fluid production in my body.
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I am currently being treated with Valproic Acid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weight loss
Secondary study objectives
Glucose Tolerance
Insulin sensitivity
Psychopathology - Brief Psychiatric Rating Scale (BPRS)
+3 more
Other study objectives
Cognition - Brief Assessment of Cognition in Schizophrenia (BACS)
Hepatic adiposity changes
Visceral adiposity changes
+1 more

Side effects data

From 2017 Phase 4 trial • 282 Patients • NCT02191579
31%
Paraesthesia
13%
Dizziness
13%
Fatigue
13%
Cognitive Disorder
13%
Nausea
11%
Decreased appetite
8%
Vision blurred
8%
Distubance in attention
7%
Sinusitis
6%
Depression
1%
Deep vein thrombosis
1%
Peripheral arterial occlusive disease
1%
Concussion
1%
Chronic obstructive pulmonary disease
1%
Nephrolithiasis
1%
Pneumonia
1%
Road traffic accident
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topiramate
BOTOX®

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topiramate
FDA approved

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
375 Previous Clinical Trials
82,837 Total Patients Enrolled
17 Trials studying Psychosis
1,939 Patients Enrolled for Psychosis
Ontario Ministry of Health and Long Term CareOTHER_GOV
91 Previous Clinical Trials
107,974 Total Patients Enrolled
Margaret Hahn, PhD, MDPrincipal InvestigatorCentre for Addiction and Mental Health

Media Library

Topiramate Clinical Trial Eligibility Overview. Trial Name: NCT02808533 — N/A
Psychosis Research Study Groups: Topiramate, Placebo
Psychosis Clinical Trial 2023: Topiramate Highlights & Side Effects. Trial Name: NCT02808533 — N/A
Topiramate 2023 Treatment Timeline for Medical Study. Trial Name: NCT02808533 — N/A
~5 spots leftby Dec 2025
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