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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight loss
Secondary outcome measures
Glucose Tolerance
Insulin sensitivity
Psychopathology - Brief Psychiatric Rating Scale (BPRS)
+3 more
Other outcome measures
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%
Cognitive Disorder
13%
Nausea
13%
Fatigue
13%
Dizziness
11%
Decreased appetite
8%
Vision blurred
8%
Distubance in attention
7%
Sinusitis
6%
Depression
1%
Peripheral arterial occlusive disease
1%
Concussion
1%
Chronic obstructive pulmonary disease
1%
Nephrolithiasis
1%
Pneumonia
1%
Road traffic accident
1%
Deep vein thrombosis
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topiramate
BOTOX®

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
351 Previous Clinical Trials
80,766 Total Patients Enrolled
58 Trials studying Schizophrenia
4,181 Patients Enrolled for Schizophrenia
Ontario Ministry of Health and Long Term CareOTHER_GOV
91 Previous Clinical Trials
107,974 Total Patients Enrolled
2 Trials studying Schizophrenia
95 Patients Enrolled for Schizophrenia
Margaret Hahn, PhD, MDPrincipal InvestigatorCentre for Addiction and Mental Health

Media Library

Topiramate Clinical Trial Eligibility Overview. Trial Name: NCT02808533 — N/A
Schizophrenia Research Study Groups: Topiramate, Placebo
Schizophrenia Clinical Trial 2023: Topiramate Highlights & Side Effects. Trial Name: NCT02808533 — N/A
Topiramate 2023 Treatment Timeline for Medical Study. Trial Name: NCT02808533 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Topiramate been scrutinized in other scientific investigations?

"Currently, 18 studies are underway to explore the potential of Topiramate. Of those ongoing investigations, 3 have advanced to Phase 3. Most trials for this medication are located in Sherbrooke, Quebec; however there is an additional 30 research sites across North America also running tests with Topiramate."

Answered by AI

Are there opportunities to enroll in this research study at the present moment?

"According to the clinicaltrials.gov entry, this medical trial is actively searching for participants and was first published on May 1st 2016 with its most recent update occurring on June 18th 2021."

Answered by AI

How many participants is the maximum capacity for this clinical experiment?

"Affirmative. Clinicaltrials.gov's listings indicate that this clinical study is still recruiting, with an initial posting of May 1st 2016 and a most recent update occurring on June 18th 2021. 50 people are needed to be enrolled from one single medical site."

Answered by AI

Are elderly individuals eligible for participation in this investigation?

"The eligibility criteria mandate that all enrollees must be aged between 17 and 59."

Answered by AI
~2 spots leftby Jul 2024