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Functional Neuroimaging in Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00343070
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : August 31, 2010
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
H. Lundbeck A/S
Information provided by:
University Hospital, Ghent

Study Description
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Brief Summary:
Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks

Condition or disease Intervention/treatment Phase
Major Depression Drug: Oral administration of escitalopram during 8 weeks Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Brain metabolism

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343070


Locations
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Belgium
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
Investigators
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Principal Investigator: Kurt Audenaert, MD, PhD University Hospital, Ghent
More Information
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Additional Information:

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Responsible Party: Kurt Audenaert, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00343070    
Other Study ID Numbers: 2006/176
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs