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12708A: An open-label study evaluating the Pharmacokinetics and Tolerability of Lu AA21004 in connection with multiple oral dosing of Lu AA21004 in child and adolescent patients with a DSM-IV-TR(TM) diagnosis of Depressive or Anxiety Disorder
This open-label study will evaluate the pharmacokinetic, tolerability and safety profiles of Lu AA21004 in connection with a multiple oral dosing in child and adolescent patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder.
This study also aims to support further development of treatment indications in the pediatric population experiencing these disorders.
Eligible participants in the pediatric (ages 7-11) or adolescent (ages 12-17) cohorts will be assigned to one of four dosing levels: 5mg, 10mg, 15mg, and 20mg. Participation in the main study will involve on-site screening and baseline evaluation visits for all participants, a 14- to 21-day treatment phase (depending on the specific dose level assigned), and a follow-up visit about two weeks after treatment completion. During the treatment phase, all participants will be required to attend 5 to 6 on-site visits (depending on the treatment arm) and be available for follow-up phone calls. Day 2, as well as the end of treatment visit, will require overnight supervision and pharmacokinetic blood sampling in an inpatient setting for about 24 hours.
Participants that have completed the main study may participate in an optional 6-month treatment extension study, even if they will turn 18 during the course of the extension. Participants who choose to enter this study will begin the same day as their end-of-treatment visit of the main study, and will report to KKI for a study visit about every 28 days for 6 months.
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