NCT00386893

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Longer than P75 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

5.2 years

First QC Date

October 10, 2006

Last Update Submit

April 13, 2015

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • changes in evoked potentials/functional MRI from baseline to week 4

    two assessments, at baseline and week 4

Study Arms (1)

Treatment as usual

OTHER

simultaneous EEG/fMRI

Procedure: simultaneous EEG/fMRIDevice: fMRI

Interventions

simultaneous EEG/fMRIPROCEDURE

fMRI/EEG recordings

Treatment as usual
fMRIDEVICE
Treatment as usual

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Clin. Radiology, Ludwig-Maximilian-University

Munich, Bavaria, D - 80336, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ulrich Hegerl, MD

    Department of Psychiatry, Ludwig-Maximilians-University

    PRINCIPAL INVESTIGATOR

  • Oliver Pogarell, MD

    Department of Psychiatry, Ludwig-Maximilians-University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 12, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

DE(1)