Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

June 30, 2015

Conditions
Depressive DisorderAnxiety Disorder
Interventions
DRUG

Vortioxetine

5 mg tablets for 14 days; orally; once daily

DRUG

Vortioxetine

10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily

DRUG

Vortioxetine

15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily

DRUG

Vortioxetine

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

Trial Locations (7)

10249

DE002, Berlin

20010

US003, Washington D.C.

44106

US001, Cleveland

45219

US002, Cincinnatti

55122

DE001, Mainz

67214

US004, Wichita

89075

DE003, Ulm

All Listed Sponsors
lead

H. Lundbeck A/S

INDUSTRY

NCT01491035 - Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder | Biotech Hunter | Biotech Hunter