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Somatosensory Processing in Depression

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Oliver Pogarell, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00386893
First received: October 10, 2006
Last updated: April 13, 2015
Last verified: April 2015
  Purpose
Aim of this study is to investigate neuronal differences (EEG/evoked potentials; functional MRI) between patients with major depression and healthy controls concerning brain activity after acute pain as well as changes of pain related brain activity during treatment with escitalopram.

Condition Intervention Phase
Depression
Procedure: simultaneous EEG/fMRI
Device: fMRI
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Influence of Escitalopram on Somatosensory Processing in Patients With Major Depression

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • changes in evoked potentials/functional MRI from baseline to week 4 [ Time Frame: two assessments, at baseline and week 4 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment as usual
simultaneous EEG/fMRI
Procedure: simultaneous EEG/fMRI
fMRI/EEG recordings
Device: fMRI

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Psychiatric in or outpatients with acute depressive episode
  • Indication for pharmacological treatment

Exclusion Criteria:

  • Acute suicidal tendency
  • Neurological or severe somatic disorders
  • Women during pregnancy or lactation
  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: NCT00386893

Locations
Germany
Department of Psychiatry and Clin. Radiology, Ludwig-Maximilian-University
Munich, Bavaria, Germany, D - 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
H. Lundbeck A/S
Investigators
Principal Investigator: Ulrich Hegerl, MD Department of Psychiatry, Ludwig-Maximilians-University
Principal Investigator: Oliver Pogarell, MD Department of Psychiatry, Ludwig-Maximilians-University
  More Information

Responsible Party: Oliver Pogarell, Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00386893     History of Changes
Other Study ID Numbers: ESC_03082005  2005-003752-35 
Study First Received: October 10, 2006
Last Updated: April 13, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 08, 2016