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Topiramate and Schizophrenia: Effects on Weight and Psychopathology

NCT02808533 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-24

No results posted yet for this study

Summary

Clozapine is the sole AP agent with superiority in treatment refractory schizophrenia, but it also is associated with the greatest risk of weight gain and other metabolic abnormalities. Topiramate, an anticonvulsant agent, possesses a weight-reducing effect. Furthermore, some studies have suggested that Topiramate may be associated with improvements in psychopathology in treatment refractory schizophrenia. Here the investigators propose to determine the role of topiramate for augmentation purposes (psychopathology) and as an adjunctive pharmacological intervention for weight loss in overweight/obese individuals with Ultra-Treatment Resistant Schizophrenia or Schizoaffective disorder taking clozapine.

Conditions

  • Schizophrenia, Schizoaffective Disorder

Interventions

DRUG

Topiramate

Topiramate capsules starting with 25 mg b.i.d with an incremental increase of 25 mg b.i.d weekly upto a maximum of 100 mg b.i.d.

OTHER

Placebo

Placebo capsules visually identical to those containing topiramate will be administered.

Sponsors & Collaborators

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Margaret Hahn, PhD, MD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808533 on ClinicalTrials.gov