Investigation of a Combination Treatment of Escitalopram and rTMS
This study has been completed.
Sponsor:
Charite University, Berlin, Germany
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
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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) |
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
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 Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 22, 2013