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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01491035
First received: November 23, 2011
Last updated: December 10, 2015
Last verified: December 2015
  Purpose
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

Condition Intervention Phase
Depressive Disorder
Anxiety Disorder
Drug: Vortioxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Cmax of Vortioxetine [ Time Frame: Day 14, 16, 18, or 20, depending on assigned dose level ] [ Designated as safety issue: No ]
    Maximum plasma concentration of vortioxetine

  • AUC(0-24h) of Vortioxetine [ Time Frame: Day 14, 16, 18 or 20, depending on assigned dose level ] [ Designated as safety issue: No ]
    Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours

  • t½ of Vortioxetine [ Time Frame: Day 14, 16, 18 or 20, depending on assigned dose level ] [ Designated as safety issue: No ]
    Half-life of vortioxetine in plasma

  • Cmax of Lu AA34443 [ Time Frame: Day 14, 16, 18, or 20, depending on assigned dose level ] [ Designated as safety issue: No ]
    Maximum plasma concentration of the major, inactive metabolite Lu AA34443

  • AUC(0-24h) of Lu AA34443 [ Time Frame: Day 14, 16, 18 or 20, depending on assigned dose level ] [ Designated as safety issue: No ]
    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: Day 14, 16, 18 or 20, depending on assigned dose level ] [ Designated as safety issue: No ]
    Half-life of the major, inactive metabolite Lu AA34443 in plasma

  • Oral Clearance (CL/F) of Vortioxetine [ Time Frame: Day 14, 16, 18 or 20, depending on assigned dose level ] [ Designated as safety issue: No ]
    Oral clearance expressed as a function of bioavailability


Enrollment: 48
Study Start Date: April 2012
Study Completion Date: June 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort CC1, 6 children Drug: Vortioxetine
5 mg tablets for 14 days; orally; once daily
Other Name: Brintellix
Experimental: Cohort CC2, 6 children Drug: Vortioxetine
10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
Other Name: Brintellix
Experimental: Cohort CC3, 6 children 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
Other Name: Brintellix
Experimental: Cohort CC4, 6 children 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
Other Name: Brintellix
Experimental: Cohort AC1, 6 adolescents Drug: Vortioxetine
5 mg tablets for 14 days; orally; once daily
Other Name: Brintellix
Experimental: Cohort AC2, 6 adolescents Drug: Vortioxetine
10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
Other Name: Brintellix
Experimental: Cohort AC3, 6 adolescents 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
Other Name: Brintellix
Experimental: Cohort AC4, 6 adolescents 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
Other Name: Brintellix

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491035

Locations
United States, District of Columbia
US003
Washington, District of Columbia, United States, 20010
United States, Kansas
US004
Wichita, Kansas, United States, 67214
United States, Ohio
US002
Cincinnatti, Ohio, United States, 45219
US001
Cleveland, Ohio, United States, 44106
Germany
DE002
Berlin, Germany, 10249
DE001
Mainz, Germany, 55122
DE003
Ulm, Germany, 89075
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01491035     History of Changes
Other Study ID Numbers: 12708A  2010-020170-42 
Study First Received: November 23, 2011
Results First Received: December 10, 2015
Last Updated: December 10, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:
Children
Adolescents
Pharmacokinetic
Pharmacodynamic

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Vortioxetine
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin 5-HT1 Receptor Antagonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Agents
Serotonin Antagonists
Serotonin Receptor Agonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on February 10, 2016