The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its metabolites in connection with multiple oral dosing in child and adolescent patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder
The study will be conducted in the US 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 for 2 to 6 days, the patients will be treated once 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. Preferably, the cohorts will be dosed in the following order: AC1, AC2, CC1, AC3, CC2, AC4, CC3, and CC4. An external data safety monitoring board (DSMB) will be established to evaluate safety, tolerability and preliminary PK data from the dosed cohort(s) prior to any dosing of subsequent cohort (s). The dose regimen may be adjusted based on the recommendation of the DSMB. Adolescents will be exposed to a certain dose of vortioxetine before children receive the same dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
5 mg tablets for 14 days; orally; once daily
10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
US003
Washington D.C., District of Columbia, United States
US004
Wichita, Kansas, United States
US002
Cincinnatti, Ohio, United States
US001
Cleveland, Ohio, United States
Cmax of Vortioxetine
Maximum plasma concentration of vortioxetine
Time frame: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level
AUC(0-24h) of Vortioxetine
Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours
Time frame: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
t½ of Vortioxetine
Half-life of vortioxetine in plasma
Time frame: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Cmax of Lu AA34443
Maximum plasma concentration of the major, inactive metabolite Lu AA34443
Time frame: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level
AUC(0-24h) of Lu AA34443
Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443
Time frame: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
t½ of Lu AA34443
Half-life of the major, inactive metabolite Lu AA34443 in plasma
Time frame: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
Oral Clearance (CL/F) of Vortioxetine
Oral clearance expressed as a function of bioavailability
Time frame: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level
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20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
DE002
Berlin, Germany
DE001
Mainz, Germany
DE003
Ulm, Germany