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Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Indiana University
Sponsor:
Collaborators:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00870727
First received: February 2, 2009
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Pervasive Developmental Disorder
Drug: aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacotherapy of Pervasive Developmental Disorders

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Clinical Global Impression - Improvement [ Time Frame: At Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist Irritability Scale [ Time Frame: At Baseline and Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Aberrant Behavior Checklist Lethargy, Stereotypy, Hyperactivity and Inappropriate Speech Subscales [ Time Frame: At Baseline and Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Double-Blind
Short term treatment where subjects will be randomized to either aripiprazole or placebo
Drug: aripiprazole
Minimum dose of 2mg per day to a maximum of 20 mg per day over the first 4 weeks of treatment.
Other Name: Abilify
Active Comparator: 2 Open-label Phase
Longer term treatment( 4 months) with Aripiprazole
Drug: aripiprazole
Minimum dose of 2mg per day to a maximum of 20 mg per day over the first 4 weeks of treatment.
Other Name: Abilify

Detailed Description:

Pervasive developmental disorders (PDD) 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 antipsychotic 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 PDD. The primary objectives of this study is to determine whether aripiprazole is effective and well tolerated for irritability in children and adolescents with PDD NOS during an 8-week acute phase and whether the effectiveness and tolerability of aripiprazole is maintained during a 16-week continuation phase.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female outpatients between the ages of 5 and 17 years and greater than or equal to 15kg body weight.
  • Diagnostic and Statistical Manual 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 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; 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 (autism, 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 averse effect] (significant tachycardia)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870727

Contacts
Contact: Arlene Kohn 317-944-1990 aekohn@iupui.edu

Locations
United States, Indiana
Riley Child and Adolescent Psychiatry Clinic- Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Arlene Kohn, BA    317-948-9766    kidpsyc@iupui.edu   
Principal Investigator: Kimberly A Stigler, MD         
Sponsors and Collaborators
Indiana University
Bristol-Myers Squibb
Investigators
Principal Investigator: Kimberly A. Stigler, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00870727     History of Changes
Other Study ID Numbers: 0805-26, MH 082119
Study First Received: February 2, 2009
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
PDD NOS

Additional relevant MeSH terms:
Child Development Disorders, Pervasive
Developmental Disabilities
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014