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Clinical Trial Details
Research Study Summary
A clinical research study of Lu AA21004 for the treatment of Depressive Disorder or Anxiety Disorder
Research 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
The study will be conducted in the USA 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 the patients will be treated 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.
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Both Male and Female
Both Male and Female ages 7 Years to 17 Years
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.
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
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
The patient meets DSM-IV-TR criteria for any psychoactive substance or alcohol use
Other inclusion and exclusion criteria may apply.
Site Locations (5)
||District of Columbia
NCT ID: NCT01491035
Date Last Changed: April 22, 2014
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