Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder
Condition: Depressive Disorder; Anxiety Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder
Intervention: Vortioxetine; Vortioxetine; Vortioxetine; Vortioxetine
Intervention description: 5 mg tablets for 14 days; orally; once daily; 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily; 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily; 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
Intervention MeSH terms: Vortioxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Children; Adolescents; Pharmacokinetic; Pharmacodynamic

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
    

Eligibility 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.