CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Vortioxetine +3 moredrug
Likely dose
Vortioxetine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01491035
NCT01491035Phase 2Completed
CompareCT.gov

An Open-label Study Evaluating the Pharmacokinetics and Tolerability of [Vortioxetine] Lu AA21004 in Connection With Multiple Oral Dosing of [Vortioxetine] Lu AA21004 in Child and Adolescent Patients With a DSM-IV Diagnosis of Depressive or Anxiety Disorder

H. Lundbeck A/S·interventional·Posted Dec 13, 2011·Updated Mar 16, 2017

In Brief

A Phase 2 clinical trial evaluating Vortioxetine for Depressive Disorder and Anxiety Disorder. Completed, enrolled 48 participants across 7 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Anxiety Disorder
CountriesGermany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2011
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.6 years ago

Interventions

Vortioxetinedrug

5 mg tablets for 14 days; orally; once daily

Vortioxetinedrug

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

Vortioxetinedrug

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

Vortioxetinedrug

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