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

February 23, 2012 updated by: Kuo-Tung Chiang, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11243
        • Beitou Armed Forces Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metformin, topiramate
Drug: metformin, topiramate
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in metabolic panel as the primary outcome
Time Frame: up to six months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (including psychiatric adverse events) as a Measure of Safety and Tolerability
Time Frame: up to six months
We use Positive and Negative Syndrome Scale, the Hamilton Depression Rating Scale, clinical golbal impression-severity, and the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale every month to investigate the participants' safety and tolerability.
up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beitou Armed Forces Hospital, Taipei, Taiwan

Investigators

  • Principal Investigator: Chiang Kuo-Tung, M.D., Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT-099-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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