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Clinical Trial Details

Overview

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

Purpose

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.

To Learn more
Phase

2

Gender

Both Male and Female

Age

7 to 17 Years

Overall Status

Recruiting

Lead Sponsor

H. Lundbeck A/S

Duration

32 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 7 Years to 17 Years

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Site Locations (5)

Country State City Zip Facility and Contact
United States District of Columbia Washington 20010 US003
United States Ohio Cincinnatti 45219 US002
United States Ohio Cleveland 44106 US001
Germany Berlin 10249 DE002
Germany Mainz 55122 DE001

Contact

Email contact via H. Lundbeck A/S

E-mail:

NCT ID: NCT01491035

Date Last Changed: November 18, 2014

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