Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

NCT ID: NCT01370291

Last Updated: 2012-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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active Risperidone and active rTMS

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

Group Type ACTIVE_COMPARATOR

active Risperidone and active rTMS

Intervention Type OTHER

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)

active rTMS and sham Risperidone

active rTMS and sham Risperidone for the first-episode schizophrenia

Group Type EXPERIMENTAL

active rTMS and sham Risperidone

Intervention Type OTHER

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)

sham rTMS and active Risperidone

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

Group Type SHAM_COMPARATOR

sham rTMS and active Risperidone

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type OTHER

Other Intervention Names

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Risperidone:Xian-Janssen pharmaceutical ltd rTMS:MagVenture Risperidone:Xian-Janssen pharmaceutical ltd rTMS: MagVenture Risperidone:Xian-Janssen pharmaceutical ltd rTMS: MagVenture

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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fengshufang

Fourth Military Medical University, Department of Psychiatry, Xi Jing hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qingrong Tan, Ph.D

Role: STUDY_DIRECTOR

Department of Psychiatry, Xi Jing hospital, Xi'an, China

Locations

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Yun chun Chen

Xi'an, Shaanxi, China

Site Status NOT_YET_RECRUITING

Yun chun Chen

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunchun Chen, Ph.D

Role: CONTACT

+086-13720582601

Shufang Feng, Ph.D

Role: CONTACT

+086-13227807801

Facility Contacts

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Yun chun Chen, Ph.D

Role: primary

+086-13720582601

Shufang Feng, Ph.D

Role: backup

+086-13227807801

Yun chun Chen, Ph.D

Role: primary

+086-13720582601

Shufang Feng, Ph.D

Role: backup

+086-13227807801

Other Identifiers

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20110526-08

Identifier Type: -

Identifier Source: org_study_id

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