Investigation of a Combination Treatment of Escitalopram and rTMS

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232700
• Other study ID #: 20050041
• Status: Completed
• Phase: N/A
• First received: October 4, 2005
• Last updated: June 22, 2011
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2007
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram

Locations

Country	Name	City	State
Germany	Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	H. Lundbeck A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
Secondary	To determine the changes of hippocampal metabolites measured by MRS
Secondary	To assess the changes of parameters of motor cortical inhibition measured by MEP
Secondary	To assess the changes of NGF and BDNF
Secondary	To determine the changes of event related potentials measured by electroencephalography

External Links

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