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NCT Number: NCT00232700

Investigation of a Combination Treatment of Escitalopram and rTMS

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, 14050, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

Primary outcomes

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

Secondary outcomes

  1. To determine the changes of hippocampal metabolites measured by MRS

  2. To assess the changes of parameters of motor cortical inhibition measured by MEP

  3. To assess the changes of NGF and BDNF

  4. To determine the changes of event related potentials measured by electroencephalography

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 5, 2005
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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