Major depressive episode Mental and Behavioural Disorders Depression
Conditions
Interventions
Participants without contraindications to study medications will be randomised to receive either escitalopram or nortriptyline orally for 12 weeks. In case of non-response or adverse reaction, the tre
it can be further increased to a maximum dose of 30 mg daily if clinically indicated
2. Nortriptyline initiated at 50 mg daily and titrated to a target dose of 100 mg daily within the
further increase to a maximum dose of 200 mg daily is possible if clinically indicated
Participants without contraindications to study medications will be randomised to receive either
Sponsors
European Commission (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of major depressive episode of at least moderate severity, as defined by the International Classification of Diseases, version 10 (ICD-10) or the Diagnostic and Statistical Manual of mental disorders - fourth edition (DSM-IV) and established in the Schedules for Clinical Assessment in Neuropsychiatry interview (SCAN version 2.1, World Health Organisation [WHO], 1999) 2. White European parentage 3. Aged 18 to 65 years 4. Participants with mild depressive symptoms on antidepressant treatment can be included if there is a history of moderate or severe symptoms during the current depressive episode 5. Individuals aged over 65 can be included if they are medically fit and not taking regular medication other than antidepressants
Exclusion criteria
Exclusion criteria: 1. Family history of bipolar affective disorder or schizophrenia in first-degree relatives 2. A personal history of hypomanic or manic episode 3. Schizophrenia 4. Mood incongruent psychotic symptoms 5. Primary substance misuse 6. Primary organic brain disease 7. Current treatment with an antipsychotic or a mood stabiliser 8. Pregnancy or lactation 9. Medical contraindications or a history of lack of efficacy or adverse reaction to both study medications 10. Previous adverse reactions or non-response to either escitalopram or citalopram are considered as contraindications to escitalopram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 17-item Hamilton Depression Rating Scale (HDRS-17) 2. Montgomery-Asberg Depression Rating Scale (MADRS) 3. Beck Depression Inventory (BDI) All primary hypotheses related to outcome and adverse reactions of medication will be based on the 8-week face-to-face assessment, controlling for the baseline values. These three measures will be integrated using Item Response Modelling. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global Assessment Scale (GAS) 2. UKU side effects rating scale 3. Antidepressant side effect scale 4. Client Service Receipt Inventory (CSRI) 5. Temperament and Character Inventory - Revised (TCI-R) 6. Brief Life Events Questionnaire (BLEQ) 7. Sexual Functioning Questionnaire (SFQ) Secondary analyses will include analysis of baseline data, and data up to week 12 and up to week 26. As there are many measures in this study and many time points, it is not possible to prestate all the secondary analyses that will be performed. | — |
Countries
Belgium, Croatia, Denmark, England, Germany, Italy, Poland, Slovenia, United Kingdom
Outcome results
None listed