NCT00870727

Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

Pharmacotherapy of Pervasive Developmental Disorders

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be more effective than placebo for reducing aggression, tantrum and self-injurious behavior in children with Pervasive Developmental Disorder.

Detailed description

Pervasive developmental disorders (PDDs) are characterized by severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics were reported in subjects with PDD, research shifted to the atypical antipsychotics which have been shown to be better tolerated and effective in this population. However, the atypical antipsychotics have also been associated with adverse effects. Thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with PDDs. The primary objectives of this study are to determine whether aripiprazole is effective and well tolerated for irritability in children and adolescents with PDD not otherwise specified (NOS) during an 8-week acute phase and whether the effectiveness and tolerability of aripiprazole is maintained during a 16-week continuation phase.

Conditions

• Pervasive Developmental Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole oral product	Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.
DRUG	Placebo oral capsule	Placebo will be identical in size and appearance to study drug.

Timeline

• Start date: 2009-02-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2009-03-27
• Last updated: 2019-01-02
• Results posted: 2018-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study