Investigation of a Combination Treatment of Escitalopram and rTMS
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation|
- Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
- To determine the changes of hippocampal metabolites measured by MRS
- To assess the changes of parameters of motor cortical inhibition measured by MEP
- To assess the changes of NGF and BDNF
- To determine the changes of event related potentials measured by electroencephalography
|Study Start Date:||September 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
We intend to test in a randomized, rater blinded, placebo controlled, prospective study the primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale compared to placebo.
A second hypothesis is that the treatment of MDE with escitalopram (that means in the "Placebo group") alone lead to typical changes like
- An increase in neurotrophic factors concentration (measured by blood concentrations of nerve growth factor (NGF) and brain derived nerve growth factor (BDNF),
- An increase in hippocampal metabolites (measured with magnetic resonance spectroscopy (MRS
- An increase in motor cortical inhibitory activity (measured with motor evoked potentials (MEP
- An increase in serotonergic activity (measured with EEG parameters, Moreover, it is hypothesized that similar but pronounced changes occur in the group treated with the combination treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232700
|Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin|
|Berlin, Germany, 14050|
|Principal Investigator:||Malek Bajbouj, MD||Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany|