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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

metformin, topiramate

About this trial

This is an interventional treatment trial for Obesity focused on measuring metformin, topiramate, obesity, metabolic syndrome

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis: schizophrenia or schizoaffective disorder
Age: 20 to 65
BMI>27
Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine)

Exclusion Criteria:

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

Sites / Locations

Beitou Armed Forces Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

metformin, topiramate

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT01384279

First Posted

June 27, 2011

Last Updated

February 23, 2012

Sponsor

Beitou Armed Forces Hospital, Taipei, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT01384279

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beitou Armed Forces Hospital, Taipei, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

metformin, topiramate, obesity, metabolic syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

metformin, topiramate

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

metformin, topiramate

Intervention Description

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

Primary Outcome Measure Information:

Title

The changes in metabolic panel as the primary outcome

Description

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

Time Frame

up to six months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

up to six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis: schizophrenia or schizoaffective disorder Age: 20 to 65 BMI>27 Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chiang Kuo-Tung, M.D.

Organizational Affiliation

Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beitou Armed Forces Hospital

City

Taipei

ZIP/Postal Code

11243

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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