Major Depressive Disorder MedDRA version: 19.0 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: Film-coated tablet
INN or Proposed INN: AGOMELATINE
CAS Number: 138112762
Current Sponsor code: S20098
Other descrip
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female outpatients - Aged between 18 and 65 years (inclusive) at the time of selection - Fulfilling DSM-IV-TR criteria for current Major Depressive Episode (MDE) = 2 - HAM-D-17 total score > = 22 - CGI-S (Severity of illness) > = 4 (moderately to severely ill) - Requiring an antidepressant treatment Are the trial subjects under 18? no Number of subjects for this age range: 0 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 MDE of mild intensity or severe episode with psychotic features, catatonic features or with duration < 4 weeks - All types of depression other than MDD, according to DSM-IV-TR criteria - 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, previous suicide attemps, quality of social and familial support - Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception. - Hepatic impairment and severe renal insufficiency Patients with known QT interval prolongation or congenital long QT syndrome. For patients with stable cardiac disease: any clinically relevant abnormality detected during the ECG likely to interfere with the study conduct or evaluations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the early effect of agomelatine on general interest in outpatient suffering from Major Depressive Disorder ;Secondary Objective: To describe/assess effects on the concentration/decision making, energy level, daytime sleepiness, severity of depression, global clinical benefit, social functioning, emotional experiences, and to provide additional safety and tolerability data on agomelatine.;Primary end point(s): General interest score obtained from the VAS reflecting the item 13 of the QIDS-SR 16 scale.;Timepoint(s) of evaluation of this end point: W1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: all over the trial;Secondary end point(s): Secondary objectives: The secondary objectives are to compare agomelatine and escitalopram’s effects on the: - Concentration/decision making - Energy level - Daytime sleepiness - Severity of depression - Global clinical benefit - Social functioning - Emotional experiences and to provide additional safety and tolerability data on agomelatine. | — |
Countries
Romania
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed