Status:
COMPLETED
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Depressive Disorder
Anxiety Disorder
Eligibility:
All Genders
7-17 years
Phase:
PHASE2
Brief 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 o...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01491035
Start Date
April 1 2012
End Date
June 1 2015
Last Update
March 16 2017
Active Locations (7)
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1
US003
Washington D.C., District of Columbia, United States, 20010
2
US004
Wichita, Kansas, United States, 67214
3
US002
Cincinnatti, Ohio, United States, 45219
4
US001
Cleveland, Ohio, United States, 44106