- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370291
Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients (rTMSfMRI)
February 13, 2012 updated by: fengshufang, Xijing Hospital
Repetitive Transcranial Magnetic Stimulation (rTMS) for First-episode Schizophrenia Patients:A Double-blinded , Randomized and Functional Magnetic Resonance Imaging (fMRI)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
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yunchun Chen, Ph.D
- Phone Number: +086-13720582601
- Email: Yunchunchen@163.com
Study Contact Backup
- Name: Shufang Feng, Ph.D
- Phone Number: +086-13227807801
- Email: fangshuan1984@yahoo.com.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Not yet recruiting
- Yun chun Chen
-
Contact:
- Shufang Feng, Ph.D
- Phone Number: +086-13227807801
- Email: fangshuan1984@yahoo.com.cn
-
Contact:
- Yun chun Chen, Ph.D
- Phone Number: +086-13720582601
- Email: Yunchunchen@163.com
-
Principal Investigator:
- Min Xi, M.D
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Yun chun Chen
-
Contact:
- Shufang Feng, Ph.D
- Phone Number: +086-13227807801
- Email: fangshuan1984@yahoo.com.cn
-
Contact:
- Yun chun Chen, Ph.D
- Phone Number: +086-13720582601
- Email: Yunchunchen@163.com
-
Principal Investigator:
- Min Xi, M.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Implanted pacemaker
- Medication pump
- Vagal stimulator
- Deep brain stimulator
- Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: active Risperidone and active rTMS
active Risperidone and active rTMS for the first-episode schizophrenia patients
|
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)
Other Names:
|
Experimental: active rTMS and sham Risperidone
active rTMS and sham Risperidone for the first-episode schizophrenia
|
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)
Other Names:
|
Sham Comparator: sham rTMS and active Risperidone
sham rTMS and active Risperidone for the first-episode schizophrenia patients
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PANSS
Time Frame: 1-6 weeks
|
1-6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total AHRS score
Time Frame: 1-6 weeks
|
1-6 weeks
|
HAMD Score
Time Frame: 1-6 weeks
|
1-6 weeks
|
CGI
Time Frame: 1-6 weeks
|
1-6 weeks
|
fMRI
Time Frame: 0,6 week
|
0,6 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Qingrong Tan, Ph.D, Department of Psychiatry, Xi Jing hospital, Xi'an, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
June 8, 2011
First Submitted That Met QC Criteria
June 8, 2011
First Posted (Estimate)
June 9, 2011
Study Record Updates
Last Update Posted (Estimate)
February 15, 2012
Last Update Submitted That Met QC Criteria
February 13, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- 20110526-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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