The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity
1 other identifier
interventional
25
1 country
1
Brief Summary
The primary aim of the study is to investigate the efficacy of metformin and topiramate on second-generation antipsychotic-induced obesity. The secondary domain we look at is the adverse effects of both drugs. The investigators hypothesize that metformin and topiramate are effective in treating obesity induced by second-generation antipsychotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2011
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 24, 2012
February 1, 2012
7 months
June 27, 2011
February 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The changes in metabolic panel as the primary outcome
Metabolic panel, which includes HDL-C, VLDL, LDL, cholesterol, triglycerides, insulin, leptin, BW, Glucose, blood pressure, and weight(with waist circumference and BMI) will be assessed every month
up to six months
Secondary Outcomes (1)
Number of Participants with Adverse Events (including psychiatric adverse events) as a Measure of Safety and Tolerability
up to six months
Study Arms (1)
metformin, topiramate
EXPERIMENTALInterventions
metformin 250 mg/d is gradually increased to 1000 mg/d over four weeks, and topiramate 50 mg/d is gradually increased to 200 mg/d over four weeks
Eligibility Criteria
You may qualify if:
- Diagnosis: schizophrenia or schizoaffective disorder
- Age: 20 to 65
- BMI\>27
- Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine)
You may not qualify if:
- Allergy to metformin or topiramate
- Currently taking metformin or topiramate
- Currently taking drugs that may interact with topiramate, including carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, amitriptyline, lithium, metformin, propranolol, and sumatriptan.
- Being pregnant or planning to become pregnant during the study period,
- History of hypertension, DM, liver or renal function impairment, cardiovascular disease, CVA, or neurological disorders
- History of hypoglycemia
- History of suicidal attempt
- Current scale of Hamilton Depression Rating Scale\>8
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beitou Armed Forces Hospital
Taipei, 11243, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiang Kuo-Tung, M.D.
Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Beitou Armed Forces Hospital
Study Record Dates
First Submitted
June 27, 2011
First Posted
June 29, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
February 24, 2012
Record last verified: 2012-02