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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: metformin, topiramate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin, topiramate<br> | Drug: metformin, topiramate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metformin, topiramate, obesity, metabolic syndrome