Investigation of a Combination Treatment of Escitalopram and rTMS

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00232700
First received: October 4, 2005
Last updated: June 22, 2011
Last verified: September 2007

October 4, 2005
June 22, 2011
September 2005
December 2008   (final data collection date for primary outcome measure)
Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
Same as current
Complete list of historical versions of study NCT00232700 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Investigation of a Combination Treatment of Escitalopram and rTMS
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Escitalopram
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00232700
20050041
Not Provided
Not Provided
Charite University, Berlin, Germany
H. Lundbeck A/S
Principal Investigator: Malek Bajbouj, MD Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany
Charite University, Berlin, Germany
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP