Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01370291

Acronym

rTMSfMRI

Enrollment

Registered

2011-06-09

Start date

2011-06-30

Completion date

2013-12-31

Last updated

2012-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

rTMS, Risperidone

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

Interventions

OTHERactive 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)

OTHERactive 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)

OTHERsham rTMS and active Risperidone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
PANSS	1-6 weeks

Secondary

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

Countries

China

Contacts

Primary ContactYunchun Chen, Ph.D

Yunchunchen@163.com+086-13720582601

Backup ContactShufang Feng, Ph.D

fangshuan1984@yahoo.com.cn+086-13227807801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026