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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Schizophrenia; Mania

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102479

31-03-238

Details and patient eligibility

About

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

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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