Brief Summary

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Official Title: "A Double-blind Placebo Controlled Trial the Comparison of Effectiveness of Repetitive TMS and iTBS on Negative Symptoms and Cognition in Patients With Schizophrenia"

The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and durable effects to the apply traditional rTMS protocols. The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in patients with schizophrenia. In a randomized, double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions. The negative symptoms and cognitive functioning will be assessed before the treatment (pre test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA apply before and after rTMS in all subjects.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Study Primary Completion Date: November 2011

Interventions Used in this Clinical Trial

• Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )
  • 3 pulses at 50Hz repeated each 200 ms for 2 seconds 80% MT 20 days treatment
• Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
  • LDLPFC 110% MT 15 Hz 20 days
• Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
  • Placebo treatment: Sham coil

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: intermittent theta burst stimulation
• Active Comparator: repetitive Transcranial Magnetic Stimulation
• Placebo Comparator: Sham TMS

Outcome Measures for this Clinical Trial

Primary Measures

• Positive and negative syndrome scale ( PANSS )
  • Time Frame: Change of baseline in negative symptoms at 20 sessions
    Safety Issue?: No

Secondary Measures

• Calgary depression for schizophrenia scale (CDSS)
  • Time Frame: 3 times (Before treatment, session 10, immediately after treatment)
    Safety Issue?: No
• Schizophrenia quality of life scale (SQLS)
  • Time Frame: 3 times (Before treatment, session 10, immediately after treatment)
    Safety Issue?: No
• Social and occupational functioning Assessment scale (SOFAS)
  • Time Frame: 3 times(Before treatment, session 10, immediately after treatment)
    Safety Issue?: No
• Neuropsychology battery test
  • Time Frame: 3 times (Before treatment, session 10, immediately after treatment)
    Safety Issue?: No
• QEEG and low resolution brain electromagnetic tomography (LORETA)
  • Time Frame: 2 times (Before treatment, immediately after treatment)
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

1. Outpatients male and female with the range of 18-50 years of age

2. The diagnosis of schizophrenia according to DSM-IV-TR

3. Completion of consent form

4. Being under supervision of a psychiatrist,

5. Being able to adhere to treatment schedule,

6. Having stable symptoms as defined by not requiring a change in antipsychotic medication for at least 4 weeks or at least 2 weeks for psychotropic agents prior to entering the Study

Exclusion Criteria

1. The history of rTMS treatment for any reason

2. Intracranial implant and other ferromagnetic materials close to the head

3. Cardiac pacemaker

4. Drug pumps

5. Acute heart attack

6. The risk of seizure with any reasons

7. High intracranial pressure

8. The history of epilepsy or seizure in the first relatives

9. Any metal in head

10. Brain trauma

11. History of loss of consciousness for more than 5 minutes

12. Pregnancy

13. Breastfeeding

14. Drug dependency

15. High risk of suicide

16. Significant positive symptoms

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • University of Tehran
• Collaborator
  • Atieh comprehensive psyche and nerve center
• Provider of Information About this Clinical Study
  • Dr.Reza rostami, Department of psychology
• Overall Contact(s)
  • Reza kazemi, MA, 009802184012128, rezakazemi@ut.ac.ir