Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Aarhus |
---|---|
Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00622947 |
The aim of the present study is to compare the antidepressant effect of low frequency rTMS applied over the right temporal cortex with sham stimulation.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder |
Procedure: right temporal low frequency (1 hz) rTMS Procedure: Sham-rTMS |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham. A Clinical Controlled, Randomized, Blinded Study. |
Estimated Enrollment: | 130 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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.
|
2: Placebo Comparator |
Procedure: Sham-rTMS
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Aarhus University Hospital | |
Risskov, Denmark, 8240 | |
Denmark, Risskov | |
University Hospital of Aarhus, Risskov | |
Aarhus, Risskov, Denmark, 8240 |
Principal Investigator: | Poul Erik B Hansen, consultant | University Hospital og Aarhus, Denmark |
Responsible Party: | University Hospital of Aarhus, Risskov, Denmark ( Poul Erik Buchholtz Hansen, senior phys., study principal investigator ) |
Study ID Numbers: | M-20070144 |
Study First Received: | January 24, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00622947 |
Health Authority: | Denmark: National Board of Health |
Depression antidepressant effect rTMS sham |
cognition saliva cortisol brain derived neurotropic factor |
Hydrocortisone Depression Cortisol succinate Clotrimazole Mental Disorders Miconazole |
Tioconazole Mood Disorders Salicylhydroxamic acid Hydrocortisone acetate Depressive Disorder Behavioral Symptoms |
Trypanocidal Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents |
Therapeutic Uses Antifungal Agents Pharmacologic Actions |