Investigation of a Combination Treatment of Escitalopram and rTMS

Charité University Medicine Berlin

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Drug: Escitalopram

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00232700

20050041

Details and patient eligibility

About

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

Full description

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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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