Functional Neuroimaging in Depression

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Major Depression

Treatments: Drug: Oral administration of escitalopram during 8 weeks

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00343070

2006/176

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)