Functional Neuroimaging in Depression

This study has been completed.
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
H. Lundbeck A/S
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00343070
First received: June 19, 2006
Last updated: August 30, 2010
Last verified: August 2010
  Purpose

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.

Resource links provided by NLM:


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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343070

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

Additional Information:
No publications provided

Responsible Party: Kurt Audenaert, University Hospital Ghent
ClinicalTrials.gov 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:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 29, 2014