NCT01370291

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Jun 2011

Typical duration for phase_3 schizophrenia

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

1.5 years

First QC Date

June 8, 2011

Last Update Submit

February 13, 2012

Conditions

Schizophrenia

Keywords

rTMSRisperidone

Outcome Measures

Primary Outcomes (1)

  • PANSS

    1-6 weeks

Secondary Outcomes (4)

  • Total AHRS score

    1-6 weeks

  • HAMD Score

    1-6 weeks

  • CGI

    1-6 weeks

  • fMRI

    0,6 week

Study Arms (3)

active Risperidone and active rTMS

ACTIVE COMPARATOR

active Risperidone and active rTMS for the first-episode schizophrenia patients

Other: active Risperidone and active rTMS

active rTMS and sham Risperidone

EXPERIMENTAL

active rTMS and sham Risperidone for the first-episode schizophrenia

Other: active rTMS and sham Risperidone

sham rTMS and active Risperidone

SHAM COMPARATOR

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

Other: sham rTMS and active Risperidone

Interventions

active Risperidone and active rTMSOTHER

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)

Also known as: Risperidone:Xian-Janssen pharmaceutical ltd, rTMS:MagVenture
active Risperidone and active rTMS
active rTMS and sham RisperidoneOTHER

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)

Also known as: Risperidone:Xian-Janssen pharmaceutical ltd, rTMS: MagVenture
active rTMS and sham Risperidone
sham rTMS and active RisperidoneOTHER

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)

Also known as: Risperidone:Xian-Janssen pharmaceutical ltd, rTMS: MagVenture
sham rTMS and active Risperidone

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yun chun Chen

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Yun chun Chen

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Qingrong Tan, Ph.D

    Department of Psychiatry, Xi Jing hospital, Xi'an, China

    STUDY DIRECTOR

Central Study Contacts

Yunchun Chen, Ph.D

CONTACT

+086-13720582601Yunchunchen@163.com

Shufang Feng, Ph.D

CONTACT

+086-13227807801fangshuan1984@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fourth Military Medical University, Department of Psychiatry, Xi Jing hospital

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 9, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations

CN(2)