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Completed

NCT Number: NCT01491035

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

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

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Key information

Conditions

Depressive Disorder Anxiety Disorder Anxiety Disorders Mental Disorders Mood Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

DE002, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vortioxetine

Drug

5 mg tablets for 14 days; orally; once daily

Other names: Brintellix

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Dec 13, 2011
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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