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

Schizophrenia Clinical Trial

— rTMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168311
• Other study ID #: 81/02
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: April 15, 2012
• Start date: August 2002
• Est. completion date: July 2007

Study information

• Verified date: April 2012
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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 TMS

Locations

Country	Name	City	State
Australia	Alfred Psychiatry Research Centre	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale for the Asessment of Negative Symptoms (SANS)	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	No