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Could a common seizure drug help schizophrenia patients lose weight and feel better?

NCT ID NCT02808533

Disease control Sponsor: Centre for Addiction and Mental Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding topiramate (a seizure medication) to clozapine can help with weight loss and improve symptoms in people with treatment-resistant schizophrenia or schizoaffective disorder. About 50 overweight or obese adults aged 17-59 who are already on clozapine will receive either topiramate or a placebo. Researchers will track weight, insulin sensitivity, and psychiatric symptoms over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Topiramate (also known as Topamax)
What this could lead to
If it works, this could offer a way to manage weight gain and possibly improve psychiatric symptoms in people with hard-to-treat schizophrenia.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply widely. Topiramate can cause side effects like dizziness or cognitive issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2016

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

17 to 59 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia / schizoaffective disorder

Contacts and locations

Locations

  • Center for Addiction and Mental Health

    Toronto, Ontario, M5T 1R8, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.