Depressive DisorderPhase 2NCT01491035

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

A Phase 2 study testing Vortioxetine in people with Depressive Disorder and Anxiety Disorder, run by H. Lundbeck A/S at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Depressive Disorder, Anxiety Disorder
What is being tested?: Vortioxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 7 sitesin 2 countries
Study dates: Apr 2012to Jun 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder.
The patient and parent(s)/legal representative(s) are able to comprehend and satisfactorily comply with the protocol requirements.
Treatment with antidepressant therapy is warranted, as judged by the investigator.

Who cannot join

The patient is pregnant or breast-feeding.
The patient presents or has a history of an Axis I (DSM-IV-TR) diagnosis of Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Autism, Pervasive Developmental Disorder (PDD), Obsessive Compulsive Disorder (OCD) or Schizophrenia or Schizoaffective Disorder.
The patient has not maintained a stable dose of a methylphenidate or amphetamine for their treatment of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 4 weeks prior to the study treatment.
The patient has a known mental retardation, or clinical evidence or known social or school history indicative of mental retardation.
The patient is at significant risk of committing suicide based on history (for example previous suicide attempt) or according to the investigator's experience, or based on active suicidal ideation, intent or plan, item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS).
The subject has any concurrent illness that may affect the particular target or absorption, distribution, and elimination of the investigational medicinal product (IMP).
The patient meets DSM-IV-TR criteria for any psychoactive substance or alcohol use disorder.
Other inclusion and exclusion criteria may apply.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States4 sites

US002
Cincinnatti, Ohio, 45219
US001
Cleveland, Ohio, 44106
US003
Washington D.C., District of Columbia, 20010
US004
Wichita, Kansas, 67214

Other trials in United States

Germany3 sites

DE002
Berlin, 10249
DE001
Mainz, 55122
DE003
Ulm, 89075

Other trials in Germany

About this study

Official title: 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

Read the detailed description

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.

Conditions: Depressive Disorder, Anxiety Disorder
Being tested: Vortioxetine
Keywords: Children, Adolescents, Pharmacokinetic, Pharmacodynamic
Medical subject headings: Depressive Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01491035
Study group	Role	What they receive
Cohort CC1, 6 children	Experimental	Not described Receives: Drug: Vortioxetine
Cohort CC2, 6 children	Experimental	Not described Receives: Drug: Vortioxetine
Cohort CC3, 6 children	Experimental	Not described Receives: Drug: Vortioxetine
Cohort CC4, 6 children	Experimental	Not described Receives: Drug: Vortioxetine
Cohort AC1, 6 adolescents	Experimental	Not described Receives: Drug: Vortioxetine
Cohort AC2, 6 adolescents	Experimental	Not described Receives: Drug: Vortioxetine
Cohort AC3, 6 adolescents	Experimental	Not described Receives: Drug: Vortioxetine
Cohort AC4, 6 adolescents	Experimental	Not described Receives: Drug: Vortioxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of Vortioxetine
Maximum plasma concentration of vortioxetine
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jun 2015

First posted13 Dec 2011 (estimated)
Study startApr 2012
Primary completionDec 2014
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01491035
Sponsor's protocol ID: 12708A
Other IDs: 2010-020170-42
Status last verified: Feb 2017
First submitted: 23 Nov 2011
Last updated: 16 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Findling RL, Robb AS, DelBello MP, Huss M, McNamara NK, Sarkis EH, Scheffer RE, Poulsen LH, Chen G, Lemming OM, Auby P. A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with Depressive or Anxiety Disorders. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):47-54. doi: 10.1089/cap.2017.0047. Epub 2017 Oct 16.
PubMed 29035574

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01491035
Acronym / sponsor ID: 12708A
Conditions: Depressive Disorder, Anxiety Disorder
Keywords: Children, Adolescents, Pharmacokinetic, Pharmacodynamic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Dec 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 13 Dec 2011 (estimated)
Results: Posted 15 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Cohort CC1, 6 children	Experimental	Drug: Vortioxetine
Cohort CC2, 6 children	Experimental	Drug: Vortioxetine
Cohort CC3, 6 children	Experimental	Drug: Vortioxetine
Cohort CC4, 6 children	Experimental	Drug: Vortioxetine
Cohort AC1, 6 adolescents	Experimental	Drug: Vortioxetine
Cohort AC2, 6 adolescents	Experimental	Drug: Vortioxetine
Cohort AC3, 6 adolescents	Experimental	Drug: Vortioxetine
Cohort AC4, 6 adolescents	Experimental	Drug: Vortioxetine

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder.
The patient and parent(s)/legal representative(s) are able to comprehend and satisfactorily comply with the protocol requirements.
Treatment with antidepressant therapy is warranted, as judged by the investigator.

Key exclusion criteria (8 listed)

The patient is pregnant or breast-feeding.
The patient presents or has a history of an Axis I (DSM-IV-TR) diagnosis of Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Autism, Pervasive Developmental Disorder (PDD), Obsessive Compulsive Disorder (OCD) or Schizophrenia or Schizoaffective Disorder.
The patient has not maintained a stable dose of a methylphenidate or amphetamine for their treatment of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 4 weeks prior to the study treatment.
The patient has a known mental retardation, or clinical evidence or known social or school history indicative of mental retardation.
The patient is at significant risk of committing suicide based on history (for example previous suicide attempt) or according to the investigator's experience, or based on active suicidal ideation, intent or plan, item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VortioxetineAlso: Brintellix5 mg tablets for 14 days; orally; once daily	Drug	Cohort AC1, 6 adolescents, Cohort CC1, 6 children
VortioxetineAlso: Brintellix10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily	Drug	Cohort AC2, 6 adolescents, Cohort CC2, 6 children
VortioxetineAlso: Brintellix15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily	Drug	Cohort AC3, 6 adolescents, Cohort CC3, 6 children
VortioxetineAlso: Brintellix20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily	Drug	Cohort AC4, 6 adolescents, Cohort CC4, 6 children

Primary outcome

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

Results and safety

Results posted to the registry on 15 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adolescents, 5 mg	6	6
Adolescents, 10 mg	6	6
Adolescents, 15 mg	6	6
Adolescents, 20 mg	6	6
Children, 5 mg	6	5
Children, 10 mg	6	6
Children, 15 mg	6	6
Children, 20 mg	6	6

Primary outcome: Cmax 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. Median (Standard Deviation). Unit: ng/mL

Measure	Adolescents, 5 mg n = 5	Adolescents, 10 mg n = 6	Adolescents, 15 mg n = 6	Adolescents, 20 mg n = 6	Children, 5 mg n = 6	Children, 10 mg n = 6	Children, 15 mg n = 6	Children, 20 mg n = 6
Value	4.3 (3.7)	7.8 (2.8)	15 (6.2)	16 (8.1)	5.0 (3.3)	14 (8.2)	26 (21)	31 (20)

Population analysed: 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.

Primary outcome: AUC(0-24h) 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. Median (Standard Deviation). Unit: ng*h/mL

Measure	Adolescents, 5 mg n = 5	Adolescents, 10 mg n = 6	Adolescents, 15 mg n = 6	Adolescents, 20 mg n = 6	Children, 5 mg n = 6	Children, 10 mg n = 6	Children, 15 mg n = 6	Children, 20 mg n = 6
Value	82 (71)	144 (60)	283 (115)	304 (143)	89 (66)	261 (137)	492 (373)	562 (374)

Population analysed: Pharmacokinetic analysis set

Primary outcome: t½ 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. Median (Standard Deviation). Unit: h

Measure	Adolescents, 5 mg n = 5	Adolescents, 10 mg n = 6	Adolescents, 15 mg n = 6	Adolescents, 20 mg n = 6	Children, 5 mg n = 6	Children, 10 mg n = 6	Children, 15 mg n = 6	Children, 20 mg n = 6
Value	46 (33)	56 (19)	50 (16)	40 (10)	45 (27)	52 (18)	71 (52)	62 (23)

Population analysed: Pharmacokinetic analysis set

Primary outcome: Cmax of 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. Median (Standard Deviation). Unit: ng/mL

Measure	Adolescents, 5 mg n = 5	Adolescents, 10 mg n = 6	Adolescents, 15 mg n = 6	Adolescents, 20 mg n = 6	Children, 5 mg n = 6	Children, 10 mg n = 6	Children, 15 mg n = 6	Children, 20 mg n = 6
Value	3.5 (2.2)	14 (7.1)	16 (5.3)	38 (12)	7.8 (3.4)	15 (5.4)	20 (13)	47 (17)

Population analysed: Pharmacokinetic analysis set

Adverse events

Time frame: 4 to 5 weeks, depending on the assigned dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adolescents, 5 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Adolescents, 10 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Adolescents, 15 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Adolescents, 20 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Children, 5 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Children, 10 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Children, 15 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Children, 20 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29035574Findling RL, Robb AS, DelBello MP, Huss M, McNamara NK, Sarkis EH, Scheffer RE, Poulsen LH, Chen G, Lemming OM, Auby P. A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with Depressive or Anxiety Disorders. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):47-54. doi: 10.1089/cap.2017.0047. Epub 2017 Oct 16.
EMA EudraCT Results: 2010-020170-42Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Email contact via H. Lundbeck A/S study director

LundbeckClinicalTrials@lundbeck.com

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vortioxetine in people with Depressive Disorder and Anxiety Disorder, run by H. Lundbeck A/S at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01491035, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.