Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

Phase 3

• Conditions: Schizophrenia
• Interventions: Other: active Risperidone and active rTMS; Other: active rTMS and sham Risperidone; Other: sham rTMS and active Risperidone

• Registration Number: NCT01370291
• Lead Sponsor: Xijing Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-15
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active Risperidone and active rTMS	active Risperidone and active rTMS	active Risperidone and active rTMS for the first-episode schizophrenia patients
active rTMS and sham Risperidone	active rTMS and sham Risperidone	active rTMS and sham Risperidone for the first-episode schizophrenia
sham rTMS and active Risperidone	sham rTMS and active Risperidone	sham rTMS and active Risperidone for the first-episode schizophrenia patients

Primary Outcome Measures

Name	Time	Method
PANSS	1-6 weeks

Secondary Outcome Measures

Name	Time	Method
Total AHRS score	1-6 weeks
HAMD Score	1-6 weeks
CGI	1-6 weeks
fMRI	0,6 week

Trial Locations

Locations (1)

Yun chun Chen; 🇨🇳 Xi'an, Shaanxi, China