Depression Mental and Behavioural Disorders Major Depressive Disorder
Conditions
Interventions
Therapeutic oral doses of agomelatine and therapeutic oral doses of selective serotonin reuptake inhibitors (SSRI) for 12 weeks, a randomised double-blind period
Sponsors
Institut de Recherches Internationales Servier (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients 2. Aged between 18 and 65 years (inclusive) at the time of selection 3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria for current major depressive episode (MDE) = 2 6. Hamilton Rating Scale for Depression (HAM-D-17) total score > = 22 7. Clinical Global Impression - Severity (CGI-S) (Severity of illness) > = 4 (moderately to severely ill) 8. Requiring an antidepressant treatment
Exclusion criteria
Exclusion criteria: 1. Patient fulfilling DSM-IV-TR criteria for a MDE of mild intensity or severe episode with psychotic features,catatonic features or with duration <4 weeks 2. All types of depression other than MDD, according to DSM-IV-TR criteria 3. Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score of 4 at the item 3 of the HAM-D-17 and/or in the investigator's opinion based on the patient's medical history, previoussuicide attempts, quality of social and familial support 4. Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception 5. Hepatic impairment 6. Severe renal insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General interest score obtained from the Visual Analogue Scale (VAS) reflecting the item 13 of the QIDS-SR 16 scale | — |
Secondary
| Measure | Time frame |
|---|---|
| To provide additional efficacy, safety and tolerability data on agomelatine | — |
Countries
Romania
Outcome results
None listed