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

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beitou Armed Forces Hospital

Taipei, 11243, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin, topiramate

Drug

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 outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Beitou Armed Forces Hospital, Taipei, Taiwan

Other Gov

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Jun 29, 2011
Registry last updated: Feb 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed