Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

Study Overview
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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

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: active Risperidone and active rTMS
* Other: active rTMS and sham Risperidone
* Other: sham rTMS and active Risperidone


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active Risperidone and active rTMS<br>active Risperidone and active rTMS for the first-episode schizophrenia patients | Other: active Risperidone and active rTMS<br>* 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)<br>* Other names: rTMS:MagVenture;|
| Experimental: active rTMS and sham Risperidone<br>active rTMS and sham Risperidone for the first-episode schizophrenia | Other: active rTMS and sham Risperidone<br>* 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)<br>* Other names: rTMS: MagVenture;|
| Sham Comparator: sham rTMS and active Risperidone<br>sham rTMS and active Risperidone for the first-episode schizophrenia patients | Other: sham rTMS and active Risperidone<br>* 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)<br>* Other names: rTMS: MagVenture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS |  | 1-6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, Risperidone