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The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity

Information source: Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: metformin, topiramate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Beitou Armed Forces Hospital, Taipei, Taiwan

Official(s) and/or principal investigator(s):
Chiang Kuo-Tung, M.D., Principal Investigator, Affiliation: Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan


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.

Clinical Details

Official title: The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The changes in metabolic panel as the primary outcome

Secondary outcome: Number of Participants with Adverse Events (including psychiatric adverse events) as a Measure of Safety and Tolerability


Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. Diagnosis: schizophrenia or schizoaffective disorder 2. Age: 20 to 65 3. BMI>27 4. Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine) Exclusion Criteria: 1. Allergy to metformin or topiramate 2. Currently taking metformin or topiramate 3. Currently taking drugs that may interact with topiramate, including carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, amitriptyline, lithium, metformin, propranolol, and sumatriptan. 4. Being pregnant or planning to become pregnant during the study period, 5. History of hypertension, DM, liver or renal function impairment, cardiovascular disease, CVA, or neurological disorders 6. History of hypoglycemia 7. History of suicidal attempt 8. Current scale of Hamilton Depression Rating Scale>8

Locations and Contacts

Beitou Armed Forces Hospital, Taipei 11243, Taiwan
Additional Information

Starting date: May 2011
Last updated: February 23, 2012

Page last updated: August 23, 2015

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