Investigation of a Combination Treatment of Escitalopram and rTMS
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|ClinicalTrials.gov Identifier: NCT00232700|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : June 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Escitalopram||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|