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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kuo-Tung Chiang, Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier:
NCT01384279
First received: June 27, 2011
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Drug: metformin, topiramate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Beitou Armed Forces Hospital, Taipei, Taiwan:

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.


Enrollment: 25
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384279

Locations
Taiwan
Beitou Armed Forces Hospital
Taipei, Taiwan, 11243
Sponsors and Collaborators
Beitou Armed Forces Hospital, Taipei, Taiwan
Investigators
Principal Investigator: Chiang Kuo-Tung, M.D. Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
  More Information

No publications provided

Responsible Party: Kuo-Tung Chiang, Beitou Armed Forces Hospital, Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier: NCT01384279     History of Changes
Other Study ID Numbers: BT-099-03
Study First Received: June 27, 2011
Last Updated: February 23, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Beitou Armed Forces Hospital, Taipei, Taiwan:
metformin
topiramate
obesity
metabolic syndrome

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Metformin
Antipsychotic Agents
Topiramate
Hypoglycemic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on May 19, 2013