Investigation of a Combination Treatment of Escitalopram and rTMS

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Depressive Episode (according to DSM IV standards) HAMD > 20 Patient has an IQ > 70 based on the investigator´s judgement Patient is male or nonpregnant female adequately protected from conception Patient is able to comply with all testing and follow-up visit requirements defined by the study protocol Patient has voluntarily signed an informed consent in accordance with institutional policies Exclusion Criteria: Patient has a history of schizophrenia, schizoaffective disorder or delusional disorder Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnestic or other cognitive disorder per DSM IV Patient is suicidal Patient has had an alcohol or substance dependence within the previous 12 month Patient is currently enrolled in another investigational study Patient has a history of, or evidence of, significant central nervous disease (especially seizures) Patient has previously been treated with escitalopram Contraindication against escitalopram or rTMS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Escitalopram|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder, Repetitive transcranial magnetic stimulation