An open-label study evaluating the Pharmacokinetics and Tolerability of Lu AA21004 in connection with multiple oral dosing of Lu AA21004 in child and adolescent patients with a DSM-IV-TRTM diagnosis of Depressive or Anxiety Disorder

H. Lundbeck A/S0 个研究点目标入组 48 人开始时间: 2012年1月30日最近更新: 2015年10月26日

试验速览

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•- 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

•- 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

发起方