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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Drug: metformin, topiramate

• Registration Number: NCT01384279
• Lead Sponsor: Beitou Armed Forces Hospital, Taipei, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-23
• Last Update Posted: 2012-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin, topiramate	metformin, topiramate	-

Primary Outcome Measures

Name	Time	Method
The changes in metabolic panel as the primary outcome	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beitou Armed Forces Hospital; 🇨🇳 Taipei, Taiwan