The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham
|Depressive Disorder||Procedure: right temporal low frequency (1 hz) rTMS Procedure: Sham-rTMS||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham. A Clinical Controlled, Randomized, Blinded Study.|
- The total 17-item score on the Hamilton scale for depression [ Time Frame: 4 weeks of treatment and 4 weeks of follow-up ]
- The outcome of the UKU side effect scale [ Time Frame: During 4 weeks of treatment and 4 weeks of follow-up ]
|Study Start Date:||February 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular is used. Low frequency rTMS at 1 Hz of right temporal cortex. Each session covering 2 trains of 60 sec. and 180 sec intertrain interval.
Procedure: right temporal low frequency (1 hz) rTMS
A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular coil is used. Low frequency rTMS at 1 Hz of right temporal cortex. Each session covering 2 trains of 60 sec. and 180 sec intertrain interval.
|Placebo Comparator: 2||
The coil is angled 90 degrees away from the scalp
TMS complies focal stimulation of the brain through a time varying magnetic field. Clinical controlled trials indicate that rTMS of the dorsolateral prefrontal cortex may have an antidepressant effect and no serious side effects. Several clinical controlled studies investigating the antidepressant effect of low as well as high frequency rTMS of the right and left prefrontal cortex have been carried out with varying results.Research on the issue suffer from small and selected study populations.There is a need for additional clinical controlled studies on larger samples and methodological investigations to clarify what is the optimal stimulus design for the treatment of depressed patients.
Recent research indicates that Depression is associated with an increased metabolic activity of subcortical areas especially the right hippocampus of the brain.
Remission of depression symptoms is associated with normalisation of the described subcortical hyperactivity. Low frequency rTMS has shown to be associated with sustained reduction in neuronal activity.
There may be an association between the activity decreasing effect of low frequency rTMS and reduction in psychiatric symptoms.
We want to test the hypothesis that low frequency rTMS of the right temporal subcortical areas (Hippocampus and and the parahippocampal part of CNS) may perform an antidepressant effect by normalizing the described hyperactivity of the subcortical areas in depressed patients.
In addition we want to test whether blood concentration of Brain Derived Neurotropic Factor( BDNF), the BDNF-genotype and saliva cortisol may be of predictive value in depressed patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622947
|University Hospital of Aarhus, Risskov|
|Aarhus, Risskov, Denmark, 8240|
|Principal Investigator:||Poul Erik B Hansen, consultant||University Hospital og Aarhus, Denmark|