Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

NCT ID: NCT00870727

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2015-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1. Aripiprazole oral product

Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Group Type: EXPERIMENTAL

Aripiprazole oral product

Intervention Type: DRUG

Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Arm 2. Placebo oral capsule

Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Placebo will be identical in size and appearance to study drug.

Interventions

Aripiprazole oral product

Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Intervention Type: DRUG

Placebo oral capsule

Placebo will be identical in size and appearance to study drug.

Intervention Type: DRUG

Other Intervention Names

Abilify; Sugar pill

Eligibility Criteria

Inclusion Criteria

• Male and female outpatients between the ages of 5 and 17 years and greater than or equal to 15 kg body weight.
• Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revised (DSM-IV-TR) diagnosis of Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS).
• Psychotropic medication-free for at least 2 days prior to screening laboratory tests and electrocardiogram (ECG).
• Significant irritability as determined by a Clinical Global Impression Severity score of greater or equal to 4 (Moderately ill) and a score of equal to or greater than 18 on the Aberrant Behavior Checklist Irritability Subscale.
• Intelligence quotient (IQ) of equal to or greater than 50 based on the Wechsler Intelligence Scale for Children (WISC), 4th edition; the Leiter International Test of Intelligence-Revised will be used if a child is nonverbal but thought to have an IQ greater than or equal to 50.

Exclusion Criteria

• DSM-IV-TR diagnosis other than PDD NOS (autistic disorder, Asperger's disorder, Rett's disorder, or childhood disintegrative disorder), schizophrenia, bipolar disorder or substance abuse within the last 6 months.
• Comorbid disorder with possible association to autism (e.g., Fragile X Syndrome, Tuberous Sclerosis).
• A significant medical condition such as heart, liver, renal, or pulmonary disease, or a seizure disorder, as determined by history, physical examination, or laboratory testing.
• Subjects with an active seizure disorder (history of febrile seizures in early childhood will be considered.
• Females with a positive urine pregnancy test.
• Evidence of a prior adequate trial of aripiprazole (defined as equal to or greater than 2 weeks at equal to or greater than 5 mg per day. When there is not evidence of a prior adequate trial, subjects must be medication-free for a least 2 weeks prior to baseline.
• History of neuroleptic malignant syndrome.
• Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study, including being unable to comply with the requirements of the study for any reason.
• Hypersensitivity to aripiprazole [e.g., allergic response or serious adverse effect] (significant tachycardia).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly A. Stigler, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Riley Hospital for Children, Christian Sarkine Autism Treatment Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

MH 082119

Identifier Type: -

Identifier Source: secondary_id

0805-26

Identifier Type: -

Identifier Source: org_study_id