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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00168311




Registration number
NCT00168311
Ethics application status
Date submitted
14/09/2005
Date registered
15/09/2005
Date last updated
14/05/2012

Titles & IDs
Public title
A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia
Scientific title
A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magentic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia and Related Disorders
Secondary ID [1] 0 0
81/02
Universal Trial Number (UTN)
Trial acronym
rTMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcranial Magnetic Stimulation
Treatment: Devices - sham TMS

Experimental: Active Treatment - Bilateral high frequency (10 Hertz) rTMS

Sham Comparator: Sham rTMS - Bilateral Sham rTMS


Treatment: Devices: 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.

Treatment: Devices: sham TMS


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00168311
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul B Fitzgerald, MBBS, PhD
Address 0 0
Alfred Psychiatry Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications