Pharmacokinetics and safety of agomelatine in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with Major Depressive Disorder.

Phase 1

• Conditions: Depressive or Anxiety Disorder; MedDRA version: 17.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 17.0Level: PTClassification code 10057666Term: Anxiety disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-003404-12-EE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-31
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

-Children aged from 7 to less than 12 years of age or adolescents from 12 to less than 18 years of age,
-Primary diagnosis of Depressive or Anxiety Disorder, as per DSM-IV-TR criteria
-Wash-out periods for forbidden treatments are respected
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
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

-Patients not living with their legal representative, living in a foster home or in an community home,
-Post-pubertal (i.e. who already have had menarche), and sexually active female not taking an oral contraceptive pill or a contraceptive implant or patch judged by the investigator to be effective,
- Pregnant or breastfeeding female
-Known hypersensitivity to agomelatine and/or to one of the excipients,
-ASAT and/or ALAT and/or Total bilirubin and/or ALP out of normal ranges,
-Positive screening for hepatitis A, B, C screening, not explained by vaccination,
-Severe renal impairment (creatinine clearance < 30 mL/min),
-Positive urinary drug screening,
-Positive breath alcohol test.
-Hepatic impairment (i.e. active liver disease)
-Patients who have a high suicidal risk according to the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified