Investigation of a Combination Treatment of Escitalopram and rTMS

NCT00232700 | Completed

• 1 other identifier: 20050041
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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

Interventions

Escitalopram DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

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

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Malek Bajbouj, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 23, 2011

Record last verified: 2007-09

Locations

DE (1)