Topiramate and Schizophrenia: Effects on Weight and Psychopathology
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|ClinicalTrials.gov Identifier: NCT02808533|
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia, Schizoaffective Disorder||Drug: Topiramate Other: Placebo||Not Applicable|
Schizophrenia is a chronic illness characterized by social and vocational disruptive functioning. While >70% of individuals with first episode illness respond to antipsychotics (APs), there remains a subgroup left with persisting psychotic symptoms. For these individuals, clozapine (CLZ) is also the sole drug with treatment superiority, but also carries the greatest metabolic liability. Another complicating factor in those treated with CLZ is the observation that while effective in some, 40-70% of individuals fail to show significant improvement with CLZ, often leading to augmentation strategies. While controlled trials are, in general lacking, a number of agents have been suggested as useful. One such group of medications includes the anticonvulsants.
Topiramate represents one of the newer anticonvulsant agents approved for the treatment of epilepsy and prophylaxis of migraines. Importantly, topiramate possesses a weight-reducing effect that has been substantiated by a meta-analysis in non-psychiatric patients. Interestingly, topiramate has been studied as an adjunctive therapy in treatment-resistant schizophrenia with some evidence demonstrating small to moderate benefits with topiramate augmentation on psychopathology. However, these benefits must also be weighed against reports (primarily from epilepsy populations), that topiramate may cause cognitive dysfunction.
This study will examine:
- Topiramate-related effects on weight
- Topiramate-related effects on glucose tolerance and insulin sensitivity
- Topiramate-related effects on psychopathology and cognition
- Topiramate-related effects on adiposity
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Topiramate in Treatment Refractory Psychotic Illness: Effects on Weight Gain and Psychopathology|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Topiramate will be dispensed on a biweekly basis, and pill counts conducted at each visit.
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 Name: Topamax
Placebo Comparator: Placebo
Placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
Placebo capsules visually identical to those containing topiramate will be administered.
- Weight loss [ Time Frame: 16 weeks ]Measured in pounds
- Insulin sensitivity [ Time Frame: 16 weeks ]Measured through Oral Glucose Tolerance Test (pmol/L)
- Psychopathology - Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 16 weeks ]Anchored scale to rate positive and negative psychiatric symptoms
- Glucose Tolerance [ Time Frame: 16 weeks ]Measured through Oral Glucose Tolerance Test (mmol/L)
- Psychopathology - Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 16 weeks ]Anchored rating scale for psychiatric symptoms
- Psychopathology - Clinical Global Impression (CGI) [ Time Frame: 16 weeks ]Anchored scale to rate global impression of patient
- Psychopathology - Global Assessment of Functioning (GAF) [ Time Frame: 16 weeks ]Anchored scale to rate global functioning of patient
- Visceral adiposity changes [ Time Frame: Baseline and 16 weeks ]Measured through MRI
- Cognition - Brief Assessment of Cognition in Schizophrenia (BACS) [ Time Frame: 16 weeks ]A standardized assessment of cognitive in patients with schizophrenia
- Volumetric Brain changes [ Time Frame: Baseline and 16 weeks ]Measured through MRI
- Hepatic adiposity changes [ Time Frame: Baseline and 16 weeks ]Measured through MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808533
|Contact: Margaret Hahn, PhD, MD||416-535-8501 ext firstname.lastname@example.org|
|Contact: Quinn A Casuccio-Treen, BSc||416-535-8501 ext email@example.com|
|Center for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M5T 1R8|
|Contact: Margaret K Hahn, MD 4165358501 ext 34368 firstname.lastname@example.org|
|Contact: Quinn A Casuccio-Treen, HBSc 4165358501 ext 34719 email@example.com|
|Principal Investigator: Margaret K Hahn, MD, PhD|
|Principal Investigator:||Margaret Hahn, PhD, MD||Centre for Addiction and Mental Health|