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Investigation of a Combination Treatment of Escitalopram and rTMS

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, Repetitive transcranial magnetic stimulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2005
Last Updated
June 22, 2011
Sponsor
Charite University, Berlin, Germany
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00232700
Brief Title
Investigation of a Combination Treatment of Escitalopram and rTMS
Official Title
Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
H. Lundbeck A/S

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Repetitive transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Escitalopram
Primary Outcome Measure Information:
Title
Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
Secondary Outcome Measure Information:
Title
To determine the changes of hippocampal metabolites measured by MRS
Title
To assess the changes of parameters of motor cortical inhibition measured by MEP
Title
To assess the changes of NGF and BDNF
Title
To determine the changes of event related potentials measured by electroencephalography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malek Bajbouj, MD
Organizational Affiliation
Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
14050
Country
Germany

12. IPD Sharing Statement

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Investigation of a Combination Treatment of Escitalopram and rTMS

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