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

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
active Risperidone and active rTMS
active rTMS and sham Risperidone
sham rTMS and active Risperidone
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring rTMS, Risperidone

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yun chun Chen
  • Yun chun ChenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

active Risperidone and active rTMS

active rTMS and sham Risperidone

sham rTMS and active Risperidone

Arm Description

active Risperidone and active rTMS for the first-episode schizophrenia patients

active rTMS and sham Risperidone for the first-episode schizophrenia

sham rTMS and active Risperidone for the first-episode schizophrenia patients

Outcomes

Primary Outcome Measures

PANSS

Secondary Outcome Measures

Total AHRS score
HAMD Score
CGI
fMRI

Full Information

First Posted
June 8, 2011
Last Updated
February 13, 2012
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01370291
Brief Title
Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients
Acronym
rTMSfMRI
Official Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for First-episode Schizophrenia Patients:A Double-blinded , Randomized and Functional Magnetic Resonance Imaging (fMRI)Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
rTMS, Risperidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active Risperidone and active rTMS
Arm Type
Active Comparator
Arm Description
active Risperidone and active rTMS for the first-episode schizophrenia patients
Arm Title
active rTMS and sham Risperidone
Arm Type
Experimental
Arm Description
active rTMS and sham Risperidone for the first-episode schizophrenia
Arm Title
sham rTMS and active Risperidone
Arm Type
Sham Comparator
Arm Description
sham rTMS and active Risperidone for the first-episode schizophrenia patients
Intervention Type
Other
Intervention Name(s)
active Risperidone and active rTMS
Other Intervention Name(s)
Risperidone:Xian-Janssen pharmaceutical ltd, rTMS:MagVenture
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
active rTMS and sham Risperidone
Other Intervention Name(s)
Risperidone:Xian-Janssen pharmaceutical ltd, rTMS: MagVenture
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
sham rTMS and active Risperidone
Other Intervention Name(s)
Risperidone:Xian-Janssen pharmaceutical ltd, rTMS: MagVenture
Intervention Description
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)
Primary Outcome Measure Information:
Title
PANSS
Time Frame
1-6 weeks
Secondary Outcome Measure Information:
Title
Total AHRS score
Time Frame
1-6 weeks
Title
HAMD Score
Time Frame
1-6 weeks
Title
CGI
Time Frame
1-6 weeks
Title
fMRI
Time Frame
0,6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: Implanted pacemaker Medication pump Vagal stimulator Deep brain stimulator Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunchun Chen, Ph.D
Phone
+086-13720582601
Email
Yunchunchen@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shufang Feng, Ph.D
Phone
+086-13227807801
Email
fangshuan1984@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingrong Tan, Ph.D
Organizational Affiliation
Department of Psychiatry, Xi Jing hospital, Xi'an, China
Official's Role
Study Director
Facility Information:
Facility Name
Yun chun Chen
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun chun Chen, Ph.D
Phone
+086-13720582601
Email
Yunchunchen@163.com
First Name & Middle Initial & Last Name & Degree
Shufang Feng, Ph.D
Phone
+086-13227807801
Email
fangshuan1984@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Min Xi, M.D
Facility Name
Yun chun Chen
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun chun Chen, Ph.D
Phone
+086-13720582601
Email
Yunchunchen@163.com
First Name & Middle Initial & Last Name & Degree
Shufang Feng, Ph.D
Phone
+086-13227807801
Email
fangshuan1984@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Min Xi, M.D

12. IPD Sharing Statement

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Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

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