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Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients (rTMSfMRI)

This study is currently recruiting participants.
Verified February 2012 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
fengshufang, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01370291
First received: June 8, 2011
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  Purpose

The aim of the study is to evaluate the effects of repetitive transcranial magnetic stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings


Condition Intervention Phase
Schizophrenia
 Other: active Risperidone and active rTMS
Other: active rTMS and sham Risperidone
Other: sham rTMS and active Risperidone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) for First-episode Schizophrenia Patients:A Double-blinded , Randomized and Functional Magnetic Resonance Imaging (fMRI)Study

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • PANSS [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total AHRS score [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]
  • HAMD Score [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]
  • CGI [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]
  • fMRI [ Time Frame: 0,6 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active Risperidone and active rTMS
active Risperidone and active rTMS for the first-episode schizophrenia patients
 Other: active Risperidone and active rTMS
active Risperidone:------- active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC) negative symptoms:high-frequency（10Hz）applied over the left temporoparietal cortex(LTPC)
Other Names:
  • Risperidone:Xian-Janssen pharmaceutical ltd
  • rTMS:MagVenture
Experimental: active rTMS and sham Risperidone
active rTMS and sham Risperidone for the first-episode schizophrenia
 Other: active rTMS and sham Risperidone
active Risperidone:------- ; active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC); negative symptoms:high-frequency（10Hz）applied over the left temporoparietal; cortex(LTPC)
Other Names:
  • Risperidone:Xian-Janssen pharmaceutical ltd
  • rTMS: MagVenture
Sham Comparator: sham rTMS and active Risperidone
sham rTMS and active Risperidone for the first-episode schizophrenia patients
 Other: sham rTMS and active Risperidone
active Risperidone:------- ; active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC); negative symptoms:high-frequency（10Hz）applied over the left temporoparietal; cortex(LTPC)
Other Names:
  • Risperidone:Xian-Janssen pharmaceutical ltd
  • rTMS: MagVenture

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 16-45 years
  • Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
  • PANSS>=60
  • First episode, and the patients haven't use any antipsychotic drugs

Exclusion Criteria:

  • Suicide risk
  • Diagnose of substance abuse/dependance
  • Severe uncontrolled organic disease that may interfere in the patient´s participation in the study

  • Contraindication to TMS:

    1. Implanted pacemaker
    2. Medication pump
    3. Vagal stimulator
    4. Deep brain stimulator
    5. Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
    6. Signs of increased intracranial pressure
  • Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
  • Estimated IQ less than 80
  • Have a sibling or parent with epilepsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370291

Contacts
Contact: Yunchun Chen, Ph.D +086-13720582601 Yunchunchen@163.com
Contact: Shufang Feng, Ph.D +086-13227807801 fangshuan1984@yahoo.com.cn

Locations
China, Shaanxi
Yun chun Chen Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yun chun Chen, Ph.D     +086-13720582601     Yunchunchen@163.com    
Contact: Shufang Feng, Ph.D     +086-13227807801     fangshuan1984@yahoo.com.cn    
Principal Investigator: Min Xi, M.D            
Yun chun Chen Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yun chun Chen, Ph.D     +086-13720582601     Yunchunchen@163.com    
Contact: Shufang Feng, Ph.D     +086-13227807801     fangshuan1984@yahoo.com.cn    
Principal Investigator: Min Xi, M.D            
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Qingrong Tan, Ph.D Department of Psychiatry, Xi Jing hospital, Xi'an, China
  More Information

No publications provided

Responsible Party: fengshufang, Fourth Military Medical University, Department of Psychiatry, Xi Jing hospital, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01370291     History of Changes
Other Study ID Numbers: 20110526-08
Study First Received: June 8, 2011
Last Updated: February 13, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
rTMS
Risperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013