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

This study has been completed.

Sponsor:

Information provided by:

Otsuka Pharmaceutical Development & Commercialization, Inc.

ClinicalTrials.gov Identifier:

NCT00102479

First received: January 29, 2005

Last updated: April 13, 2006

Last verified: April 2006

History of Changes

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study to Test PK Tolerability in Children and Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

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 ClinicalTrials.gov Identifier (NCT Number):

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.

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

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

Pharmacokinetics,
Aripiprazole
acute mania in pediatric populations

Additional relevant MeSH terms:

Schizophrenia
Bipolar Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Aripiprazole
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013

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