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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 March 03, 2015
Central Nervous System Agents
Physiological Effects of Drugs