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

Beitou Armed Forces Hospital, Taipei, Taiwan

Status: Completed

Conditions: Obesity

Treatments: Drug: metformin, topiramate

Study type: Interventional

Funder types: Other

Identifiers

NCT01384279

BT-099-03

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 1 patient group

metformin, topiramate

Experimental group

Treatment:

Drug: metformin, topiramate