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.
- Conditions
- Major Depressive or Anxiety DisorderMedDRA version: 17.0Level: PTClassification code 10057666Term: Anxiety disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 17.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-003404-12-HU
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
-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 Major 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
-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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate pharmacokinetics of 3 doses of agomelatine in patients from 7 to less than 18 years suffering from Major Depressive or Anxiety Disorder.;Secondary Objective: The secondary objectives are:<br>-to provide safety data of 3 doses of agomelatine,<br>-to evaluate vigilance/sedation of 3 doses of agomelatine,<br>-to evaluate the tablet acceptability of 3 doses of agomelatine.<br>;Primary end point(s): Pharmacokinetics: Cmax, AUC, t1/2, Ctrough, and tmax.;Timepoint(s) of evaluation of this end point: All over the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety:<br>-Adverse Events,<br>-Suicidality (Columbia-Suicide Severity Rating Scale Children’s version (C-SSRS-C)),<br>-Laboratory parameters,<br>-Vital signs,<br>-Body weight and BMI,<br>-12-lead ECG abnormalities.<br><br>Vigilance/sedation: using Visual Analogue Scale (Appendix 7) and Choice Reaction Time (CRT).<br>Tablet acceptability: using a tablet acceptability questionnaire ;Timepoint(s) of evaluation of this end point: All over the study