Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients
Information source: Xijing Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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
Clinical Details
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 scoreHAMD Score CGI fMRI
Eligibility
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
Locations and Contacts
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
Additional Information
Starting date: June 2011
Last updated: February 13, 2012
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