Major Depression
Conditions
Brief summary
Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks
Interventions
DRUGOral administration of escitalopram during 8 weeks
Sponsors
Fund for Scientific Research, Flanders, Belgium
H. Lundbeck A/S
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain metabolism | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive functions | — |
| Efficacy scales (mood, anxiety, anger and hopelessness) | — |
Countries
Belgium
Outcome results
None listed