Topiramate and Schizophrenia: Effects on Weight and Psychopathology

NCT02808533 | Unknown

• 1 other identifier: 097/2015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Measured in pounds

  16 weeks

Secondary Outcomes (6)

• Insulin sensitivity

  16 weeks

• Psychopathology - Positive and Negative Syndrome Scale (PANSS)

  16 weeks

• Glucose Tolerance

  16 weeks

• Psychopathology - Brief Psychiatric Rating Scale (BPRS)

  16 weeks

• Psychopathology - Clinical Global Impression (CGI)

  16 weeks

Other Outcomes (4)

• Visceral adiposity changes

  Baseline and 16 weeks

• Cognition - Brief Assessment of Cognition in Schizophrenia (BACS)

  16 weeks

• Volumetric Brain changes

  Baseline and 16 weeks

Study Arms (2)

Topiramate

EXPERIMENTAL

Topiramate will be dispensed on a biweekly basis, and pill counts conducted at each visit.

Drug: Topiramate

Placebo

PLACEBO COMPARATOR

Placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.

Other: Placebo

Interventions

Topiramate DRUG

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.

Also known as: Topamax

Topiramate

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 17 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Schizophrenia or Schizoaffective disorder
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

RECRUITING

Related Links

• The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Margaret Hahn, PhD, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Hahn, PhD, MD

CONTACT

416-535-8501; margaret.hahn@camh.ca

Quinn A Casuccio-Treen, BSc

CONTACT

416-535-8501; quinn.treen@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 21, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)