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.

Pharmacokinetics and safety of agomelatine in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with Depressive or Anxiety Disorder. An open-labelled, multicenter, three-dose level, non-comparative study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003404-12-FI

Enrollment

Registered

2013-01-14

Start date

2013-02-12

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive or Anxiety Disorder MedDRA version: 17.0 Level: PT Classification code 10057666 Term: Anxiety disorder System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 17.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: VALDOXAN Product Name: Agomelatine Product Code: S20098 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AGOMELATINE CAS Number: 138112-76-2 Current Sponsor code: S20098 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 Depressive or Anxiety Disorder.;Secondary Objective: The secondary objectives are: -to provide safety data of 3 doses of agomelatine, -to evaluate vigilance/sedation of 3 doses of agomelatine, -to evaluate the tablet acceptability of 3 doses of agomelatine. ;Primary end point(s): Pharmacokinetics: Cmax, AUC, t1/2, Ctrough, and tmax.;Timepoint(s) of evaluation of this end point: All over the study	—

Measure

Time frame

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 Depressive or Anxiety Disorder.;Secondary Objective: The secondary objectives are: -to provide safety data of 3 doses of agomelatine, -to evaluate vigilance/sedation of 3 doses of agomelatine, -to evaluate the tablet acceptability of 3 doses of agomelatine. ;Primary end point(s): Pharmacokinetics: Cmax, AUC, t1/2, Ctrough, and tmax.;Timepoint(s) of evaluation of this end point: All over the study

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Secondary

Measure	Time frame
Secondary end point(s): Safety: -Adverse Events, -Suicidality (Columbia-Suicide Severity Rating Scale Children’s version (C-SSRS-C)), -Laboratory parameters, -Vital signs, -Body weight and BMI, -12-lead ECG abnormalities. Vigilance/sedation: using Visual Analogue Scale (Appendix 7) and Choice Reaction Time (CRT). Tablet acceptability: using a tablet acceptability questionnaire ;Timepoint(s) of evaluation of this end point: All over the study	—

Measure

Time frame

Secondary end point(s): Safety: -Adverse Events, -Suicidality (Columbia-Suicide Severity Rating Scale Children’s version (C-SSRS-C)), -Laboratory parameters, -Vital signs, -Body weight and BMI, -12-lead ECG abnormalities. Vigilance/sedation: using Visual Analogue Scale (Appendix 7) and Choice Reaction Time (CRT). Tablet acceptability: using a tablet acceptability questionnaire ;Timepoint(s) of evaluation of this end point: All over the study

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Countries

Estonia, Finland, Hungary, Poland, Romania, Sweden

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33 155 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026