Investigation of a Combination Treatment of Escitalopram and rTMS

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00232700
First received: October 4, 2005
Last updated: June 22, 2011
Last verified: September 2007
  Purpose

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


Condition Intervention
Major Depressive Disorder
Drug: Escitalopram

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 42
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232700

Locations
Germany
Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 14050
Sponsors and Collaborators
Charite University, Berlin, Germany
H. Lundbeck A/S
Investigators
Principal Investigator: Malek Bajbouj, MD Department of Psychiatry, Charité - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Eschenallee 3, 14050 Berlin, Germany
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00232700     History of Changes
Other Study ID Numbers: 20050041
Study First Received: October 4, 2005
Last Updated: June 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Major depressive disorder
Repetitive transcranial magnetic stimulation

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 14, 2014