Major Depressive Disorder MedDRA version: 19.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Institut de Recherche International Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. In-or-out patients, considering that hospitalisation is not required for this study 3. Aged from 7 to less than 12 years of age (ICH E11 children age-sub-set, 2001) or from 12 to less than 18 years of age (ICH E11 adolescent age sub-set, 2001) 4. Living with their parents/ legally authorized representative(s) 5. Informed consent/assent obtained from the parents or legally authorized representative(s)/patient: to be defined according to patient’s age and corresponding regulatory requirements in the concerned countries 6. Primary diagnosis of Major Depressive Disorder, single or recurrent episode, of moderate to severe intensity, as per DSM-IV-TR criteria. The diagnosis of MDD according to DSM-IV-TR criteria will be made using a validated semi-structured interview, the Schedule for Affective Disorders and Schizophrenia for School-age Children, Present and Lifetime version Are the trial subjects under 18? yes Number of subjects for this age range: 484 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any non-selection criterion which could have appeared after the selection visit 2. Any clinically significant abnormality detected during physical examination, ECG, laboratory test and likely to interfere with the study conduct or evaluation 3. Transaminases values (AST and/or ALT) > 2 times the upper limit of normal range (ULN), total bilirubin > 1.5 times ULN, transaminases (AST and/or ALT) and total bilirubin values > upper reference value, alkaline Phosphates (ALP) > 3 times ULN 4. All types of Depression other than Major Depressive Episode 5. Current suicide risk according to the clinical opinion of the investigator and based on the information obtained during the evaluation of the C-SSRS-C Hepatic impairment 7. Creatinine Clearance < or = 30 ml/min 8. Abnormal Thyroid Function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the antidepressant short-term efficacy of at least one of the two doses of agomelatine compared to placebo after 12 weeks of treatment in children (from 7 to less than 12 years of age) and adolescents (from 12 to less than 18 years of age) suffering from moderate to severe Major Depressive Disorder using Children Depression Rating Scale – Revised (CDRS-R);Secondary Objective: - to assess the short-term and long-term safety of agomelatine (10mg, 25mg) - to evaluate the long-term efficacy of agomelatine (10mg, 25mg) - to explore efficacy and safety in children and adolescents separately ;Primary end point(s): The CDRS-R Raw score. ;Timepoint(s) of evaluation of this end point: All visits except end visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical Global Impression: Severity of Illness (CGI-S) and Global Improvement (CGI-I) scores - Clinical Global Assessment Scale (CGAS) total score - Adolescent Depression Rating Scale (ADRS) total score (only for adolescents) - The safety endpoints: *Adverse events (AE), Pediatric Adverse Event Rating Scale (PAERS) *Clinical laboratory evaluation (biochemistry, haematology, hormonal parameters) *Vital signs and clinical examination *Electrocardiogram *Columbia Suicidide Severity Rating Scale (C-SSRS-C) *Tanner stage *Continuous Performance Task (CPT). ;Timepoint(s) of evaluation of this end point: - CGI: All visits except end visit. - CGAS and ADRS: Inclusion visit, week 4, week 8 and week 12. - Adverse events (AE): All visits, Pediatric Adverse Event Rating Scale (PAERS): from week 001 and all after visits - Clinical laboratory evaluation (biochemistry, haematology, hormonal parameters, evaluation of LFT): selection visit, week 002, 008, 012, 018, 024 052, 077 and 104 - Vital signs and clinical examination: selection visit, week 002, 008, 012, 018, 024, 052, 077 and 106 - Electrocardiogram: selection visit, week 012 and 104 - Columbia Suicidide Severity Rating Scale (C-SSRS-C): from inclusion visit and all after visit except end visit - Tanner stage: inclusion visit, week 012, 052 and 104 - Continuous Performance Task (CPT): inclusion visit, week 012, 052 and 104 | — |
Countries
Bulgaria, Finland, Germany, Hungary, Poland, Romania, Russian Federation, South Africa, Ukraine
Contacts
Public ContactClinical Studies Department
Institut de Recherche International Servier
Outcome results
None listed