Investigation of a Combination Treatment of Escitalopram and rTMS

NCT ID: NCT00232700

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-12-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Escitalopram

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Principal Investigators

Malek Bajbouj, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Berlin, , Germany

Countries

Germany

Other Identifiers

20050041

Identifier Type: -

Identifier Source: org_study_id