Functional Neuroimaging in Depression

August 30, 2010 updated by: University Hospital, Ghent

Functional Neuroimaging in Depression: Longitudinal Study of PET Metabolism in Correlation With Changes in Attentional Bias, Autobiographical Memory, Future Fluency and Facial Recognition in Depressed Patients Treated With Escitalopram.

Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

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

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Kortrijk, Belgium, 8500
        • AZ Groeninge campus Sint Maarten

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major Depression, Depressive episode, following DSM-IV criteria
  • MADRS-score > 25
  • Age: 18-65 yrs
  • Medication-free or anti-depressant wash-out 7 days (for fluoxetine: 6 weeks)
  • Lorazepam 1mg or zolpidem 10mg are allowed

Exclusion Criteria:

  • Suicidality
  • Bipolar disorder, following DSM-IV criteria
  • Psychotic symptoms
  • Substance abuse
  • Personality disorder, following DSM-IV criteria
  • Cognitive dysfunction due to trauma capitis or dementia
  • Diabetes mellitus
  • Women without contraceptive protection, with pregnancy or breast feeding
  • Pharmacological treatment or ingestion of substance that can influence cerebral perfusion less than a month before inclusion
  • IQ below 80
  • Conditions not compatible with SPC

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Brain metabolism

Secondary Outcome Measures

Outcome Measure
Cognitive functions
Efficacy scales (mood, anxiety, anger and hopelessness)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

H. Lundbeck A/S
Fund for Scientific Research, Flanders, Belgium

Investigators

  • Principal Investigator: Kurt Audenaert, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 20, 2006

First Posted (Estimate)

June 22, 2006

Study Record Updates

Last Update Posted (Estimate)

August 31, 2010

Last Update Submitted That Met QC Criteria

August 30, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/176

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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