- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386893
Somatosensory Processing in Depression
April 13, 2015 updated by: Oliver Pogarell, Ludwig-Maximilians - University of Munich
Influence of Escitalopram on Somatosensory Processing in Patients With Major Depression
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, D - 80336
- Department of Psychiatry and Clin. Radiology, Ludwig-Maximilian-University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Treatment as usual
simultaneous EEG/fMRI
|
fMRI/EEG recordings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in evoked potentials/functional MRI from baseline to week 4
Time Frame: two assessments, at baseline and week 4
|
two assessments, at baseline and week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ulrich Hegerl, MD, Department of Psychiatry, Ludwig-Maximilians-University
- Principal Investigator: Oliver Pogarell, MD, Department of Psychiatry, Ludwig-Maximilians-University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 10, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (Estimate)
October 12, 2006
Study Record Updates
Last Update Posted (Estimate)
April 14, 2015
Last Update Submitted That Met QC Criteria
April 13, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESC_03082005
- 2005-003752-35
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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