Trial Information

Official Title: 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 Diagnosis of Depressive or Anxiety Disorder

Summary

The study will be conducted in the USA and in Europe and will include paediatric patients diagnosed with depressive or anxiety disorders of two age populations; children aged 7-11 years and adolescents of the age 12-17 years. It is an open study to allow pharmacokinetic (PK) sampling of all patients, and four dose levels will be tested. Following lower initial doses the patients will be treated daily at the assigned dose levels for 14 days, and it is expected that patients may benefit from treatment during this period. As the treatment duration is not sufficient according to treatment guidelines, if judged or indicated by the investigator, the patients are offered to continue in an extension treatment of up to six months to allow possibility for therapeutic satisfaction.

Phase: Phase 2

Sponsor: H. Lundbeck A/S

Overall Contacts:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com