Functional Neuroimaging in Depression

Phase 2

Completed

• Conditions: Major Depression

• Registration Number: NCT00343070
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-20
• Study First Posted: 2006-06-22
• Study Start: 2007-03
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-30
• Last Update Posted: 2010-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Brain metabolism

Secondary Outcome Measures

Name	Time	Method
Cognitive functions
Efficacy scales (mood, anxiety, anger and hopelessness)

Trial Locations

Locations (2)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

AZ Groeninge campus Sint Maarten; 🇧🇪 Kortrijk, Belgium