Major Depressive Disorder MedDRA version: 14.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: VALDOXAN
Product Name: S20098
Product Code: S20098
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AGOMELATINE
CAS Number: 138112-76-2
Current Sponsor code: S20098
Concentration un
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female outpatients, -Aged between 18 and 65 years, -Fulfilling DSM-IV TR criteria for Major Depressive Episode of moderate or severe intensity, -Diagnosis documented using the brief structured interview M.I.N.I., -Clinical Global Impression item 1: CGI severity of illness = 4 (= from moderately ill to extremely ill), -Hospital Anxiety and Depression scale (HAD) completed, -Treated with either paroxetine or venlafaxine at therapeutic doses continuously for at least 6 weeks, -Requiring a change in antidepressant treatment due to an insufficient treatment efficacy with or without acceptability problems. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patient fulfilling DSM-IV-TR criteria for a Major Depressive Episode of mild intensity and/or episode with psychotic features, catatonic features or with duration < 6 weeks, -All types of mood disorder other than Major Depressive Disorder, according to DSM-IV TR criteria, -Patient treated within 2 weeks before selection visit with either paroxetine or venlafaxine, but in association with another antidepressant drug for more than 3 days, -“High Suicidality” according to MINI 5.0.0., -Marked suicidal intent and/or suicidal risk for the current episode, according to the investigator's opinion, -Women of childbearing potential without effective contraception, -Pregnant or breast-feeding women, -Patients treated within the 4 weeks before selection visit with either an antipsychotic or a barbiturate, - Patients treated with a depot antipsychotic within 2 injection-period time before selection visit, -Patient treated within the 2 weeks before selection visit with a benzodiazepine at a dose which is superior to the maximum recommended dosage, -Hepatic impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare three different ways to initiate agomelatine after antidepressant treatment by SSRI or SNRI (immediate substitution or 2 different therapeutic schemes with previous treatment gradual decrease).;Secondary Objective: -To document general safety, -To describe early effects on subjective sleep and daytime sleepiness, -To describe the global clinical benefit, -To provide information on emotional effects, in the context of those different ways to initiate agomelatine.;Primary end point(s): -Total number of discontinuation emergent symptoms according to the Discontinuation-Emergent Signs and Symptoms check-list.;Timepoint(s) of evaluation of this end point: - Week 0, week 1, week 2 and week 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse events - Haematology and biochemistry parameters - Vital signs (blood pressure and heart rate) - Body weight, body mass index (BMI);Timepoint(s) of evaluation of this end point: - Adverse events (evaluated at all visits) - Haematology and biochemistry parameters (at week 0 and week 3 - and week 8 for liver function only) - Vital signs (blood pressure and heart rate) - Body weight, body mass index (BMI) (ASSE, week 0, week 3 and week 8) | — |
Countries
Belgium, Brazil, France, Germany, Hungary, Italy, Portugal, Spain
Outcome results
None listed