Somatosensory Processing in Depression

Depression Clinical Trial

Official title:

Influence of Escitalopram on Somatosensory Processing in Patients With Major Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00386893
• Other study ID #: ESC_03082005
• Secondary ID: 2005-003752-35
• Status: Withdrawn
• Phase: Phase 4
• First received: October 10, 2006
• Last updated: April 13, 2015
• Start date: October 2006
• Est. completion date: December 2011

Study information

• Verified date: April 2015
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Procedure:
• simultaneous EEG/fMRI
fMRI/EEG recordings

Device:
• fMRI

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Clin. Radiology, Ludwig-Maximilian-University	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	H. Lundbeck A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in evoked potentials/functional MRI from baseline to week 4		two assessments, at baseline and week 4	No