Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

Condition(s) targeted: Schizophrenia

Intervention: active Risperidone and active rTMS (Other); active rTMS and sham Risperidone (Other); sham rTMS and active Risperidone (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Xijing Hospital

Official(s) and/or principal investigator(s):
Qingrong Tan, Ph.D, Study Director, Affiliation: Department of Psychiatry, Xi Jing hospital, Xi'an, China

Overall contact:
Yunchun Chen, Ph.D, Phone: +086-13720582601, Email: Yunchunchen@163.com

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: PANSS

Secondary outcome:

Total AHRS score

HAMD Score

CGI

fMRI

Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Both.

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:

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

Yunchun Chen, Ph.D, Phone: +086-13720582601, Email: Yunchunchen@163.com

Yun chun Chen, Xi'an, Shaanxi 710032, China; Not yet recruiting
Yun chun Chen, Ph.D, Phone: +086-13720582601, Email: Yunchunchen@163.com
Shufang Feng, Ph.D, Phone: +086-13227807801, Email: fangshuan1984@yahoo.com.cn
Min Xi, M.D, Principal Investigator

Yun chun Chen, Xi'an, Shaanxi 710032, China; Recruiting
Yun chun Chen, Ph.D, Phone: +086-13720582601, Email: Yunchunchen@163.com
Shufang Feng, Ph.D, Phone: +086-13227807801, Email: fangshuan1984@yahoo.com.cn
Min Xi, M.D, Principal Investigator

Starting date: June 2011
Last updated: February 13, 2012