Clinical trial NCT00232700: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Repetitive transcranial magnetic stimulation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2005-10-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluation of efficacy and response speed of an Escitalopram-rTMS-combination in the acute treatment of Major Depression.
Secondary outcomes:
measure: To determine the changes of hippocampal metabolites measured by MRS
measure: To assess the changes of parameters of motor cortical inhibition measured by MEP
measure: To assess the changes of NGF and BDNF
measure: To determine the changes of event related potentials measured by electroencephalography
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Study officials:
affiliation: Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany
name: Malek Bajbouj, MD
role: PRINCIPAL_INVESTIGATOR
References: