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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 4, 2005

Last Updated Date

June 22, 2011

Start Date ^ICMJE

September 2005

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00232700 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Investigation of a Combination Treatment of Escitalopram and rTMS

Official Title ^ICMJE

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

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: Escitalopram

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00232700

Other Study ID Numbers ^ICMJE

20050041

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

H. Lundbeck A/S

Investigators ^ICMJE

Principal Investigator:

Malek Bajbouj, MD

Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany

Information Provided By

Charite University, Berlin, Germany

Verification Date

September 2007

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

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