Topiramate for Schizophrenia

QA
MH
Overseen ByMargaret Hahn, PhD, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Centre for Addiction and Mental Health
Must be taking: Clozapine
Stay on Your Current MedsYou can continue your current medications while participating
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether topiramate, a medication typically used to control seizures, can aid weight loss and improve symptoms in individuals with schizophrenia or schizoaffective disorder who do not respond well to clozapine. Although clozapine is a potent antipsychotic, it often leads to weight gain and other metabolic issues. The study will compare topiramate to a placebo to determine its effectiveness in addressing these problems. Individuals with schizophrenia or schizoaffective disorder, who are taking clozapine and have a BMI of 25 or higher, may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore new treatment options for those struggling with current medications.

Will I have to stop taking my current medications?

The trial requires that you continue taking clozapine if you are already on it. However, you cannot participate if you are taking Valproic Acid, hydrochlorothiazide, or certain other medications. The protocol does not specify if you need to stop other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that topiramate is likely to be safe for humans?

Studies have shown that patients generally tolerate topiramate well. Clinical trials report common side effects such as fatigue and drowsiness. Some patients have experienced vision problems, though these are unrelated to high eye pressure. Serious side effects, such as suicidal thoughts, are rare and occur in about 1 in 500 people. Overall, research suggests that topiramate can be used safely, but monitoring for side effects remains important.12345

Why are researchers excited about this trial?

Most treatments for schizophrenia, like antipsychotics, work by blocking dopamine receptors to reduce symptoms. But Topiramate works differently, targeting glutamate pathways, which may offer a fresh approach to managing schizophrenia symptoms. This unique mechanism of action could potentially address symptoms that traditional treatments don't fully manage. Researchers are excited because this alternative pathway might lead to better outcomes for patients, especially those who don't respond well to standard therapies.

What evidence suggests that Topiramate might be an effective treatment for schizophrenia?

Research has shown that topiramate, which participants in this trial may receive, can aid individuals with schizophrenia, particularly when combined with other medications for the condition. Studies have found that it significantly reduces symptoms of schizophrenia, including positive symptoms like hallucinations and negative symptoms like emotional withdrawal. In addition to alleviating these symptoms, topiramate can assist with weight loss and management, which is crucial for those taking medications like clozapine that may cause weight gain. The treatment is generally well tolerated, with most people not experiencing severe side effects. Overall, topiramate seems to be a promising supplementary treatment for schizophrenia.678910

Who Is on the Research Team?

MH

Margaret Hahn, PhD, MD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

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.
BMI greater than or equal to 25
I am between 17 and 59 years old.
See 2 more

Exclusion Criteria

I have a history of glaucoma.
I have liver or kidney problems.
I have had kidney stones in the past.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Topiramate or placebo, with biweekly dispensing and pill counts

16 weeks
Biweekly visits for dispensing and pill counts

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Topiramate

Trial Overview

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.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TopiramateExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials
388
Recruited
84,200+

Ontario Ministry of Health and Long Term Care

Collaborator

Trials
92
Recruited
108,000+

Citations

Efficacy and tolerability of topiramate-augmentation therapy ...

Topiramate-augmentation therapy improves the psychopathology of schizophrenia with good tolerability and has the additional advantage of weight maintenance.

Efficacy for Psychopathology and Body Weight and Safety ...

Conclusions: Topiramate-antipsychotic cotreatment significantly reduced total, positive, negative, and general psychopathology and weight/BMI in ...

Efficacy and tolerability of topiramate-augmentation ...

Our results indicate that topiramate-augmentation therapy is well tolerated, can improve the psychopathology of schizophrenia, and reduces weight gain ...

Topiramate improves deficit symptoms in a patient with ...

Topiramate was shown to attenuate the severity of negative symptoms (e.g., emotional withdrawal) in a patient with schizophrenia when added to his stable ...

Topiramate and Schizophrenia: Effects on Weight and ...

while effective in some, 40-70% of individuals fail to show significant improvement with CLZ, often leading to augmentation strategies.

qudexy® xr - accessdata.fda.gov

The safety data presented below are from 249 patients with partial epilepsy on concomitant. AEDs who participated in the QUDEXY XR study [see Clinical Studies ( ...

Topiramate Clinical Data | Trokendi XR® HCP

Visual field defects (independent of elevated intraocular pressure) have been reported in patients receiving topiramate. In clinical trials, most events were ...

A review of the efficacy and safety of extended-release ... - PMC

These results indicate that USL255 reduced the impact of seizure worry without causing significant unwanted physical or mental medication side effects. Safety ...

Real-world assessment of treatment with extended-release ...

Results supported the potential for better tolerability of Trokendi XR versus TPM-IR. Formulations of topiramate are currently approved for the ...

Topiramate XR

The most common side effects with Qudexy XR or Trokendi XR are fatigue and sleepiness. If you've just started taking Qudexy XR or Trokendi XR ...