The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity
This study has been completed.
Information provided by (Responsible Party):
Kuo-Tung Chiang, Beitou Armed Forces Hospital, Taipei, Taiwan
First received: June 27, 2011
Last updated: February 23, 2012
Last verified: February 2012
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.
Drug: metformin, topiramate
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity
Primary Outcome Measures:
- The changes in metabolic panel as the primary outcome [ Time Frame: up to six months ] [ Designated as safety issue: Yes ]
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:
- Number of Participants with Adverse Events (including psychiatric adverse events) as a Measure of Safety and Tolerability [ Time Frame: up to six months ] [ Designated as safety issue: Yes ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Experimental: metformin, topiramate
Drug: metformin, topiramate
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
|Ages Eligible for Study:
||20 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosis: schizophrenia or schizoaffective disorder
- Age: 20 to 65
- Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine)
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01384279
|Beitou Armed Forces Hospital
|Taipei, Taiwan, 11243 |
Beitou Armed Forces Hospital, Taipei, Taiwan
||Chiang Kuo-Tung, M.D.
||Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
No publications provided
||Kuo-Tung Chiang, Beitou Armed Forces Hospital, Beitou Armed Forces Hospital, Taipei, Taiwan
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 27, 2011
||February 23, 2012
||Taiwan: Department of Health
Keywords provided by Beitou Armed Forces Hospital, Taipei, Taiwan:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Signs and Symptoms
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents