Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents

This study has been completed.

First Received: January 29, 2005 Last Updated: April 13, 2006 History of Changes

Sponsored by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00102479

Purpose

The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.

Condition	Intervention	Phase
Schizophrenia Mania	Drug: Aripiprazole	Phase II

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Safety Study
Official Title:	A Phase II Study to Test PK Tolerability in Children and Adolescents

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Study Start Date:	July 2004
Estimated Study Completion Date:	July 2005

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children and adolescents between 10-17 years, in good physical health, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder

Exclusion Criteria:

History of mental retardation
Any neurological disorder with the exception of Pervasive Developmental Disorder (PDD), Attention Deficit Hyperactivity Disorder (ADHD), and Tourette’s Syndrome

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Findling RL, Kauffman RE, Sallee FR, Carson WH, Nyilas M, Mallikaarjun S, Shoaf SE, Forbes RA, Boulton DW, Pikalov A. Tolerability and pharmacokinetics of aripiprazole in children and adolescents with psychiatric disorders: an open-label, dose-escalation study. J Clin Psychopharmacol. 2008 Aug;28(4):441-6.

Study ID Numbers:	31-03-238
Study First Received:	January 29, 2005
Last Updated:	April 13, 2006
ClinicalTrials.gov Identifier:	NCT00102479 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Pharmacokinetics,
Aripiprazole
acute mania in pediatric populations

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs
Central Nervous System Depressants

Psychotic Disorders
Aripiprazole
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009