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

Beitou Armed Forces Hospital, Taipei, Taiwan25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity

Interventions

metformin, topiramateDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Beitou Armed Forces Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

Time frame: up to six months

Secondary Outcomes

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.

Time frame: up to six months

Data from ClinicalTrials.gov

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