Investigation of a Combination Treatment of Escitalopram and rTMS

June 22, 2011 updated by: Charite University, Berlin, Germany

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

H. Lundbeck A/S

Investigators

  • Principal Investigator: Malek Bajbouj, MD, Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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