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Schizophrenia | Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

Schizophrenia research study

What is the primary objective of this 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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Schizophrenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:active Risperidone and active rTMSactive 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:active rTMS and sham Risperidoneactive 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:sham rTMS and active Risperidoneactive 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)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

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

Study Status

Unknown status

Start Date: June 2011

Completed Date: December 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: PANSS

Secondary Outcome: Total AHRS score

Study sponsors, principal investigator, and references

Principal Investigator: Qingrong Tan, Ph.D

Lead Sponsor: Xijing Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01370291

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