Back to resultsSomatosensory Processing in Depression
Primary Purpose
Depression
Status
Withdrawn
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
simultaneous EEG/fMRI
fMRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Depression
Eligibility 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
Sites / Locations
- Department of Psychiatry and Clin. Radiology, Ludwig-Maximilian-University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment as usual
Arm Description
simultaneous EEG/fMRI
Outcomes
Primary Outcome Measures
changes in evoked potentials/functional MRI from baseline to week 4
Secondary Outcome Measures
Full Information
NCT ID
NCT00386893
First Posted
October 10, 2006
Last Updated
April 13, 2015
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT00386893
Brief Title
Somatosensory Processing in Depression
Official Title
Influence of Escitalopram on Somatosensory Processing in Patients With Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
H. Lundbeck A/S
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
simultaneous EEG/fMRI
Intervention Type
Procedure
Intervention Name(s)
simultaneous EEG/fMRI
Intervention Description
fMRI/EEG recordings
Intervention Type
Device
Intervention Name(s)
fMRI
Primary Outcome Measure Information:
Title
changes in evoked potentials/functional MRI from baseline to week 4
Time Frame
two assessments, at baseline and week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Hegerl, MD
Organizational Affiliation
Department of Psychiatry, Ludwig-Maximilians-University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oliver Pogarell, MD
Organizational Affiliation
Department of Psychiatry, Ludwig-Maximilians-University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Clin. Radiology, Ludwig-Maximilian-University
City
Munich
State/Province
Bavaria
ZIP/Postal Code
D - 80336
Country
Germany
12. IPD Sharing Statement
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Somatosensory Processing in Depression
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