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NCT00343070 Clinical Trial

Functional Neuroimaging in Depression

Major Depression Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00343070
Other study ID # 2006/176
Secondary ID
Status Completed
Phase Phase 2
First received June 19, 2006
Last updated August 30, 2010
Start date March 2007
Est. completion date October 2009

Study information
Verified date August 2010
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oral administration of escitalopram during 8 weeks

Locations
Country Name City State
Belgium University Hospital Ghent Ghent
Belgium AZ Groeninge campus Sint Maarten Kortrijk

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Ghent Fund for Scientific Research, Flanders, Belgium, H. Lundbeck A/S

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brain metabolism
Secondary Cognitive functions
Secondary Efficacy scales (mood, anxiety, anger and hopelessness)
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