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

February 13, 2012 updated by: fengshufang, Xijing Hospital

Repetitive Transcranial Magnetic Stimulation (rTMS) for First-episode Schizophrenia Patients:A Double-blinded , Randomized and Functional Magnetic Resonance Imaging (fMRI)Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Not yet recruiting
        • Yun chun Chen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min Xi, M.D
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Yun chun Chen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min Xi, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PANSS
Time Frame: 1-6 weeks
1-6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Total AHRS score
Time Frame: 1-6 weeks
1-6 weeks
HAMD Score
Time Frame: 1-6 weeks
1-6 weeks
CGI
Time Frame: 1-6 weeks
1-6 weeks
fMRI
Time Frame: 0,6 week
0,6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Director: Qingrong Tan, Ph.D, Department of Psychiatry, Xi Jing hospital, Xi'an, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 9, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110526-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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