A study evaluating the Pharmacokinetics and Tolerability of Lu AA21004 in Child and Adolescent Patients With Depressive or Anxiety Disorder

• Conditions: DSM-IV-TRTM diagnosed Depressive or Anxiety Disorder; MedDRA version: 14.1Level: HLGTClassification code 10002861Term: Anxiety disorders and symptomsSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: HLTClassification code 10012401Term: Depressive disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-020170-42-DE
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-30
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

- Patients with DSM-IV-TR diagnosis of Depressive and Anxiety Disorder
- The patients and parent(s)/legal representative(s) are able to comprehend and satisfactorily comply with the protocol requirements
- Treatment with antidepressant is warranted, as judged by the investigator

Other inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- The patient is pregnant or breast-feeding.
- The patient presents or has a history of an Axis I (DSM-IV-TRTM) diagnosis of Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Autism, Pervasive Developmental Disorder (PDD), Obsessive Compulsive Disorder or Schizophrenia or Schizoaffective Disorder.
- The patient presents with a comorbid ADHD that requires pharmacological 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 patients meets DSM-IV-TR criteria for any psychoactive substance or alcohol use disorder

Other exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified