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

Completed · Phase 2

Conditions studied: Depressive Disorder, Anxiety Disorder

In brief

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

Key facts

Study ID

NCT01491035

Run by

H. Lundbeck A/S

People needed

48

Starts

2012-04-01

Expected to finish

2015-06-01

Last updated by the study team

2017-03-16

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.
• Other inclusion and exclusion criteria may apply.

Where it is running

• US003 — Washington D.C., District of Columbia, United States
• US004 — Wichita, Kansas, United States
• US002 — Cincinnatti, Ohio, United States
• US001 — Cleveland, Ohio, United States
• DE002 — Berlin, Germany
• DE001 — Mainz, Germany
• DE003 — Ulm, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.