A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assoc Professor Paul Fitzgerald, The Alfred
ClinicalTrials.gov Identifier:
NCT00168311
First received: September 14, 2005
Last updated: April 15, 2012
Last verified: April 2012
  Purpose

There is pilot data to suggest the therapeutic value of rTMS applied to the left prefrontal cortex in the treatment of negative symptoms. Neuroimaging studies demonstrate abnormal activity in this region in patients experiencing negative symptoms. Finally rTMS applied at high frequency shows the capacity to up-regulate cortical activity in a way that would provide an explanation for a therapeutic response.

The study involves participants receiving 15 sessions of high frequency rTMS treatment applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS. Following this double blind phase, participants randomised to placebo treatment will be offered 15 sessions of active treatment.

In addition, ppTMS (paired pulse TMS) will be conducted prior to the onset of treatment and after completion of the course, as a means of measuring cortical inhibition and facilitation. NIRS (Near Infra red spectroscopy) will also be conducted prior to, during and after the first and last treatment sessions to allow monitoring of oxygenated and deoxygenated haemoglobin.


Condition Intervention
Schizophrenia
Device: Transcranial Magnetic Stimulation
Device: sham TMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magentic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia and Related Disorders

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • Scale for the Asessment of Negative Symptoms (SANS) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Scale for Assessment of Negative Symptoms [SANS]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of >50 is considered to be a moderate-severe intensity.


Enrollment: 22
Study Start Date: August 2002
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment
Bilateral high frequency (10 Hertz) rTMS
Device: Transcranial Magnetic Stimulation
Participants were sequentially randomly assigned to either 15 active bilateral treatments or 15 sham bilateral treatments that were administered on a daily basis, five days per week.
Sham Comparator: Sham rTMS
Bilateral Sham rTMS
Device: sham TMS

Detailed Description:

The main outcome measure used is the SANS (Scale for the Assessment of Negative Symptoms. This is a semi strucutured interview which provides scores from 0-70. This is administered at baseline, week 2, 3, 5 and 6.

Other outcome measures administered are (frequency mentioned above): PANSS (Positive and Negative Syndrome Scale) and the Calgery Depression Scale for Schizophrenia, A cognitive battery is also administered.

Inclusion Criteria:

  • Diagnostic and Statistical Manual-IV diagnosis of schizophrenia or schizoaffective disorder, age over 18
  • Persistent negative symptoms of moderate to severe intensity
  • Failure to respond to a minimum of two antipsychotic medications
  • No increase or initiation of new antipsychotic therapy in the four weeks prior to entering the trial Exclusion Criteria
  • Prominent positive symptoms
  • Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
  • Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
  • Subjects at high risk of violence or suicide as determined by the investigator and treating clinicians
  • Substance dependence
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder, age over 18
  • Persistent negative symptoms of moderate to severe intensity
  • Failure to respond to a minimum of two antipsychotic medications
  • No increase or initiation of new antipsychotic therapy in the four weeks prior to entering the trial

Exclusion Criteria:

  • Prominent positive symptoms
  • Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
  • Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
  • Subjects at high risk of violence or suicide as determined by the investigator and treating clinicians
  • Substance dependence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168311

Locations
Australia, Victoria
Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
The Alfred
Investigators
Principal Investigator: Paul B Fitzgerald, MBBS, PhD Alfred Psychiatry Research Centre
  More Information

No publications provided

Responsible Party: Assoc Professor Paul Fitzgerald, Professor, The Alfred
ClinicalTrials.gov Identifier: NCT00168311     History of Changes
Other Study ID Numbers: 81/02
Study First Received: September 14, 2005
Results First Received: June 15, 2010
Last Updated: April 15, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The Alfred:
Transcranial Magnetic Stimulation
Schizophrenia
Negative Symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014