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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-07-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia Mania

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

References

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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. doi: 10.1097/JCP.0b013e31817dd520.

Reference Type DERIVED

PMID: 18626272 (View on PubMed)

Other Identifiers

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31-03-238

Identifier Type: -

Identifier Source: org_study_id