Major Depressive Disorder Clinical Trial
Official title:
Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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