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

NCT01491035 | Completed Phase 2 Results DMC

• 2 other identifiers: 12708A2010-020170-42
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 7

Brief 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

Conditions

Depressive Disorder; Anxiety Disorder

Keywords

Children; Adolescents; Pharmacokinetic; Pharmacodynamic

Outcome Measures

Primary Outcomes (7)

• Cmax of Vortioxetine

  Maximum plasma concentration 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

• AUC(0-24h) of Vortioxetine

  Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours

  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

  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

  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

  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

  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

  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

Study Arms (8)

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

Interventions

Vortioxetine DRUG

5 mg tablets for 14 days; orally; once daily

Also known as: Brintellix

Cohort AC1, 6 adolescents; Cohort CC1, 6 children

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (7)

US003

Washington D.C., District of Columbia, 20010, United States

Location

US004

Wichita, Kansas, 67214, United States

Location

US002

Cincinnatti, Ohio, 45219, United States

Location

US001

Cleveland, Ohio, 44106, United States

Location

DE002

Berlin, 10249, Germany

Location

DE001

Mainz, 55122, Germany

Location

DE003

Ulm, 89075, Germany

Location

Related Publications (1)

• 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.

  PMID: 29035574 DERIVED

Related Links

• EMA EudraCT Results: 2010-020170-42

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: H. Lundbeck
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: December 13, 2011
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 16, 2017
• Results First Posted: January 15, 2016

Record last verified: 2017-02

Locations

DE (3); US (4)