Trial · NCT01491035

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

NCT01491035, Phase 2, Completed, H. Lundbeck A/S; results first posted 2016-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder. Trials, record NCT01491035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01491035

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder
NCT number: NCT01491035
Status: Completed
Phases: Phase 2
Enrollment: 48 participants, actual
Lead sponsor: H. Lundbeck A/S
Conditions: Depressive Disorder, Anxiety Disorder
Interventions: Vortioxetine, Vortioxetine, Vortioxetine, Vortioxetine
First posted: 2011-12-13
Last updated: 2017-03-16
Other registries' IDs: eudract:2010-020170-42
Results first posted: 2016-01-15

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cmax of Vortioxetine	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	Maximum plasma concentration of vortioxetine
Primary	AUC(0-24h) of Vortioxetine	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	Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours
Primary	t½ of Vortioxetine	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	Half-life of vortioxetine in plasma
Primary	Cmax of Lu AA34443	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	Maximum plasma concentration of the major, inactive metabolite Lu AA34443
Primary	AUC(0-24h) of Lu AA34443	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	Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443
Primary	t½ of Lu AA34443	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	Half-life of the major, inactive metabolite Lu AA34443 in plasma
Primary	Oral Clearance (CL/F) of Vortioxetine	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 expressed as a function of bioavailability

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cmax of Vortioxetine	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	Pharmacokinetic analysis set = all patients who took at least one dose of IMP and who contributed with both Day 1 pre-dose pharmacokinetic sampling data and sufficient post-dose sampling data for estimation of the pharmacokinetic parameters.	ng/mL	MEDIAN
PRIMARY	AUC(0-24h) of Vortioxetine	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	Pharmacokinetic analysis set	ng*h/mL	MEDIAN
PRIMARY	t½ of Vortioxetine	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	Pharmacokinetic analysis set	h	MEDIAN
PRIMARY	Cmax of Lu AA34443	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	Pharmacokinetic analysis set	ng/mL	MEDIAN
PRIMARY	AUC(0-24h) of Lu AA34443	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	Pharmacokinetic analysis set	ng*h/mL	MEDIAN
PRIMARY	t½ of Lu AA34443	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	Pharmacokinetic analysis set	h	MEDIAN
PRIMARY	Oral Clearance (CL/F) of Vortioxetine	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	Pharmacokinetic analysis set	L/h	MEDIAN

Source ClinicalTrials.gov

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Cmax of Vortioxetine	Adolescents, 5 mg	4.3	Standard Deviation 3.7	ng/mL
Cmax of Vortioxetine	Adolescents, 10 mg	7.8	Standard Deviation 2.8	ng/mL
Cmax of Vortioxetine	Adolescents, 15 mg	15	Standard Deviation 6.2	ng/mL
Cmax of Vortioxetine	Adolescents, 20 mg	16	Standard Deviation 8.1	ng/mL
Cmax of Vortioxetine	Children, 5 mg	5.0	Standard Deviation 3.3	ng/mL
Cmax of Vortioxetine	Children, 10 mg	14	Standard Deviation 8.2	ng/mL
Cmax of Vortioxetine	Children, 15 mg	26	Standard Deviation 21	ng/mL
Cmax of Vortioxetine	Children, 20 mg	31	Standard Deviation 20	ng/mL
AUC(0-24h) of Vortioxetine	Adolescents, 5 mg	82	Standard Deviation 71	ng*h/mL
AUC(0-24h) of Vortioxetine	Adolescents, 10 mg	144	Standard Deviation 60	ng*h/mL

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Adolescents, 5 mg	6
Overall Study	STARTED	Adolescents, 10 mg	6
Overall Study	STARTED	Adolescents, 15 mg	6
Overall Study	STARTED	Adolescents, 20 mg	6
Overall Study	STARTED	Children, 5 mg	6
Overall Study	STARTED	Children, 10 mg	6
Overall Study	STARTED	Children, 15 mg	6
Overall Study	STARTED	Children, 20 mg	6
Overall Study	COMPLETED	Adolescents, 5 mg	6
Overall Study	COMPLETED	Adolescents, 10 mg	6

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events328

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Adolescents, 5 mg	0	6
other	Abdominal pain	Gastrointestinal disorders	Adolescents, 10 mg	0	6
other	Abdominal pain	Gastrointestinal disorders	Adolescents, 15 mg	0	6
other	Abdominal pain	Gastrointestinal disorders	Adolescents, 20 mg	0	6
other	Abdominal pain	Gastrointestinal disorders	Children, 5 mg	2	6
other	Abdominal pain	Gastrointestinal disorders	Children, 10 mg	0	6
other	Abdominal pain	Gastrointestinal disorders	Children, 15 mg	0	6
other	Abdominal pain	Gastrointestinal disorders	Children, 20 mg	0	6
other	Abdominal pain upper	Gastrointestinal disorders	Adolescents, 5 mg	0	6
other	Abdominal pain upper	Gastrointestinal disorders	Adolescents, 10 mg	0	6

1 to 10 of 328Source ClinicalTrials.gov

See all 328 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Adolescents, 5 mg
Total, all-cause mortality	Adolescents, 10 mg
Total, all-cause mortality	Adolescents, 15 mg
Total, all-cause mortality	Adolescents, 20 mg
Total, all-cause mortality	Children, 5 mg
Total, all-cause mortality	Children, 10 mg
Total, all-cause mortality	Children, 15 mg
Total, all-cause mortality	Children, 20 mg
Total, other adverse events	Adolescents, 5 mg	4	6
Total, other adverse events	Adolescents, 10 mg	4	6

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29035574	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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