- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168311
A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia (rTMS)
A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magentic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia and Related Disorders
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3181
- Alfred Psychiatry Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Treatment
Bilateral high frequency (10 Hertz) rTMS
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scale for the Asessment of Negative Symptoms (SANS)
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul B Fitzgerald, MBBS, PhD, Alfred Psychiatry Research Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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