Active not recruitingNAINTERVENTIONAL

Topiramate and Schizophrenia: Effects on Weight and Psychopathology

This study is investigating if Topiramate, a medication sometimes used for epilepsy or migraines, can help people with schizophrenia or schizoaffective disorder who are undergoing treatment with another medication called clozapine. Clozapine is very effective for some, but can cause weight gain and other health issues. Researchers want to see if adding Topiramate to clozapine treatment can help manage weight and improve mental health symptoms. They will also look at how it affects things like blood sugar and thinking skills. This research is important because it could offer new ways to help people living with these conditions.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre for Addiction and Mental Health

Enrolment target

Start

01 May 2016

Estimated completion

01 Aug 2026

Schizophrenia, Schizoaffective Disorder

What is this study about?

Many people with schizophrenia or schizoaffective disorder take a medication called clozapine because it's often the most helpful option, especially for those whose symptoms are tough to treat. However, clozapine can sometimes cause unwanted side effects, like weight gain and changes in how the body handles sugar.

This study is looking into whether another medicine called Topiramate can help. Topiramate is already known to help with weight loss in some people and has also shown promise in improving mental health symptoms for those with schizophrenia. The main goal is to see if adding Topiramate to a clozapine treatment plan can not only help people lose weight but also make them feel better mentally.

The researchers will closely watch several things to understand how Topiramate works. They will check its effects on weight, blood sugar levels, and thinking skills, as well as mental health symptoms. This study aims to find better ways to support people managing schizophrenia or schizoaffective disorder, especially when they are already taking clozapine.

Key takeaways

This study explores a new way to help with schizophrenia/schizoaffective disorder.
It focuses on managing weight gain and improving mental health symptoms.
Participants will continue taking their clozapine medication.
Researchers will monitor weight, thinking skills, and blood sugar levels.
The study compares Topiramate with a placebo (dummy pill).

Who may be eligible?

To join this study, you need to be between 17 and 59 years old and have a diagnosis of schizophrenia or schizoaffective disorder. You also need to be taking the medication clozapine at a certain dose for at least 12 weeks and be considered overweight or obese.

There are also some reasons why you might not be able to join. For example, if you have certain health conditions affecting your liver, kidneys, or heart, or if you have a history of kidney stones or glaucoma. Women who could become pregnant must be using effective birth control, and pregnant or breastfeeding women cannot take part. If you have a problem with alcohol, or if you've recently had a major medical event or started new medications for blood sugar or cholesterol, you might not be eligible. Also, if Topiramate hasn’t worked for you in the past or caused problems, you won't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 17 and 59 years old?
Do you have a diagnosis of schizophrenia or schizoaffective disorder?
Are you currently taking clozapine medication?
Are you considered overweight or obese?
Do you have good kidney and liver function?
Are you female and using contraception (if applicable)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either Topiramate or a placebo (a dummy pill with no active medicine) in addition to your regular clozapine. You will have regular visits to the study clinic where the team will monitor your weight, blood sugar, and mental health symptoms. You may also have some tests to check your thinking skills. The study will involve several visits over a period of time, and you will be carefully followed up to see how the medication affects you. The total duration of your participation will be explained to you in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as improvements in weight and mental health symptoms. However, as with any medication, Topiramate can have side effects, including potential effects on thinking and other areas. The study team will closely monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Center for Addiction and Mental Health
Verified postcode
Toronto, Canada

Common questions

What is clozapine?

Clozapine is a powerful medication often used for schizophrenia when other treatments haven't worked well.

What is Topiramate typically used for?

Topiramate is usually prescribed for epilepsy and to prevent migraine headaches.

What is a placebo?

A placebo is a 'dummy pill' that looks like the study medication but doesn't contain any active medicine. It helps researchers compare the real drug's effects.

Will I know if I'm getting Topiramate or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know who is getting Topiramate and who is getting the placebo until the study ends.

How long will the study last?

The total length of time you'd be involved in the study will be explained in full by the research team if you are suitable to take part.