Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients (rTMSfMRI)

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 3

Conditions: Schizophrenia

Treatments: Other: active Risperidone and active rTMS; Other: active rTMS and sham Risperidone; Other: sham rTMS and active Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT01370291

20110526-08

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

active Risperidone and active rTMS

Active Comparator group

Description:

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

Treatment:

Other: active Risperidone and active rTMS

active rTMS and sham Risperidone

Experimental group

Description:

active rTMS and sham Risperidone for the first-episode schizophrenia

Treatment:

Other: active rTMS and sham Risperidone

sham rTMS and active Risperidone

Sham Comparator group

Description:

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

Treatment:

Other: sham rTMS and active Risperidone