NCT Number: NCT00343070
Functional Neuroimaging in Depression
Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
University Hospital Ghent, Ghent, Belgium
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Brain metabolism
Secondary outcomes
-
Cognitive functions
-
Efficacy scales (mood, anxiety, anger and hopelessness)
Sponsors and collaborators
Lead sponsor
University Hospital, Ghent
Other
Collaborators
- Fund for Scientific Research, Flanders, Belgium
- H. Lundbeck A/S
Registry information
Official study 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.
Important dates
- Study start
- 2007
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Jun 22, 2006
- Registry last updated
- Aug 31, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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