Functional Neuroimaging in Depression

This study has been completed.
Fund for Scientific Research, Flanders, Belgium
H. Lundbeck A/S
Information provided by:
University Hospital, Ghent Identifier:
First received: June 19, 2006
Last updated: August 30, 2010
Last verified: August 2010

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

Condition Intervention Phase
Major Depression
Drug: Oral administration of escitalopram during 8 weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Brain metabolism

Secondary Outcome Measures:
  • Cognitive functions
  • Efficacy scales (mood, anxiety, anger and hopelessness)

Estimated Enrollment: 40
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00343070

University Hospital Ghent
Ghent, Belgium, 9000
AZ Groeninge campus Sint Maarten
Kortrijk, Belgium, 8500
Sponsors and Collaborators
University Hospital, Ghent
Fund for Scientific Research, Flanders, Belgium
H. Lundbeck A/S
Principal Investigator: Kurt Audenaert, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Kurt Audenaert, University Hospital Ghent Identifier: NCT00343070     History of Changes
Other Study ID Numbers: 2006/176
Study First Received: June 19, 2006
Last Updated: August 30, 2010
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Behavioral Symptoms processed this record on March 26, 2015