Major Depression
Conditions
Interventions
Trade Name: Cipralex® 10 mg - Filmtabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Escitalopram
Other descriptive name: Escitalopram oxalate
Concentration unit: mg milligram(s)
Concentration
Sponsors
Medical University of Vienna, University Department of Psychiatry and Psychotherapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General • General health based on medical history, physical examination and vital signs at screening. • Male and female subjects, age 18 to 55 years • Willingness and competence to sign the informed consent form • Right-handedness • Non-smoker (less than 5 cigarettes per week) • Body weight 50-100 kg (BMI 19-26) Depressed Patients • DSM-V diagnosis of MDD following SCID I, HDRS29, MADRS and BDI Healthy subjects • Mental health based on history and initial screening (HDRS = 8, MADRS = 6 and BDI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Current or history of psychiatric or neurological disease (other than MDD) • Current medical illness requiring treatment (other than MDD) • Current or former psychopharmacological treatment within the last 6 months • Previous escitalopram intake • Hypersensitivity to escitalopram • Acute suicidality • Pregnancy or currently breastfeeding • Current or former substance or alcohol abuse • Any contraindication for MRI e.g. (implants, stainless steel graft, claustrophobia) • Failure to comply with the study protocol or to follow the instruction of the investigating team • Summed radiation exposure in this study and the past 10 years exceeds 30 mSv (limit for 10 years acc. to Austrian Radiation Protection Law “Med. Strahlenschutzverordnung 2020, §25 (3)”
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess alterations in (R)-11C-Me-NB1 NMDA receptor binding in predefined brain regions in unmedicated patients with MDD compared to healthy volunteers • To analyze potential treatment effects of an antidepressant (escitalopram) and psychotherapy on GluN2B-containing NMDA receptors in patients with MDD in a longitudinal, double-blind, randomized, placebo-controlled design;Secondary Objective: To test associations between treatment changes (as measured by psychiatric tests) and (R)-11C-Me-NB1 NMDA receptor binding;Primary end point(s): Changes in GluN2B-containing NMDA receptor binding (PET);Timepoint(s) of evaluation of this end point: Data analysis will be performed 42 days (+/- 2 days) after study participation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Associated changes in HDRS = 8, MADRS = 6 and BDI < 13 or = 50 % reduction;Timepoint(s) of evaluation of this end point: Data analysis will be performed 42 days (+/- 2 days) after study participation | — |
Countries
Austria
Contacts
Public ContactNEUROIMAGING LABS
Medical University of Vienna, University Department of Psychiatry and Psychotherapy
Outcome results
None listed