Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

Schizophrenia Clinical Trial

— rTMSfMRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01370291
• Other study ID #: 20110526-08
• Status: Recruiting
• Phase: Phase 3
• First received: June 8, 2011
• Last updated: February 13, 2012
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2012
• Source: Xijing Hospital
• Contact: Yunchun Chen, Ph.D
• Phone: +086-13720582601
• Email: Yunchunchen[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• active 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)
• active 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)
• sham rTMS and active 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)

Locations

Country	Name	City	State
China	Yun chun Chen	Xi'an	Shaanxi
China	Yun chun Chen	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS		1-6 weeks	No
Secondary	Total AHRS score		1-6 weeks	No
Secondary	HAMD Score		1-6 weeks	No
Secondary	CGI		1-6 weeks	No
Secondary	fMRI		0,6 week	No