Investigation of a Combination Treatment of Escitalopram and rTMS

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00232700
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Status Verified: 2007-09
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.

Secondary Outcome Measures

Name	Time	Method
To determine the changes of event related potentials measured by electroencephalography
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

Trial Locations

Locations (1)

Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany