Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 408 for:    ARIPIPRAZOLE

A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00198055
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date June 4, 2014
Study Start Date  ICMJE January 2005
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2007)
  • The Clinical Global Impression(CGI)Improvement Scale. [ Time Frame: Every 2 Weeks ]
  • The Irritability subscale of the Aberrant Behavior Checklist (ABC) [ Time Frame: Every 2 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • The Clinical Global Impression(CGI)Improvement Scale, every 2 weeks.
  • The Irritability subscale of the Aberrant Behavior Checklist (ABC),every two weeks
Change History Complete list of historical versions of study NCT00198055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2007)
  • The Clinical Global Impression Severity Scale. [ Time Frame: At baseline and endpoint ]
  • The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS). [ Time Frame: At baseline and endpoint ]
  • The Vineland Maladaptive Behavior Subscale. [ Time Frame: At baseline and endpoint ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • The Clinical Global Impression Severity Scale,at baseline and end point.
  • The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS), baseline and endpoint.
  • The Vineland Maladaptive Behavior Subscale, baseline and endpoint.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.
Official Title  ICMJE An Open-Label Study of Aripiprazole in Children and Adolescents With Autistic Disorder
Brief Summary The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This is an open-label investigation of aripiprazole in the management of the maladaptive behaviors of autistic disorder. We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior.
Detailed Description Pervasive developmental disorders (PDD) are characterized be 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's, 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 PDD's including Asperger's disorder and PDD Not Otherwise Specified (PDD NOS). We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior. We also hypothesize that aripiprazole will be well tolerated, with low risk for extrapyramidal symptoms, hyperprolactinemia, weight gain, or corrected QT interval (QTc) prolongation. In addition, this open-label study will serve to stimulate more definitive, controlled research.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Asperger's Disorder
  • Pervasive Developmental Disorder
Intervention  ICMJE Drug: aripiprazole
Aripiprazole 5 mg per day for 2 weeks, then can be increased to 10mg per day if tolerated for 2 weeks, then can be increased to 15 mg per day for 4 weeks.
Other Name: Abilify
Study Arms  ICMJE Experimental: Aripiprazole
Aripiprazole 5 mg per day for 2 weeks, then can be increased to 10mg per day if tolerated for 2 weeks, then can be increased to 15 mg per day for 4 weeks.
Intervention: Drug: aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2005)
25
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mental age of 18 months
  • Diagnosis of Asperger's Disorder or Pervasive Developmental Disorder
  • Good health overall
  • Free of all psychotropic medication for 2 weeks

Exclusion Criteria:

  • Weight less than 15kg
  • Subjects who have received an adequate trial of aripiprazole
  • An active seizure disorder
  • A significant medical condition
  • History of neuroleptic malignant syndrome
  • Females with positive Beta human chorionic gonadotropin(HCG) pregnancy test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00198055
Other Study ID Numbers  ICMJE 0302-24
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Indiana University ( Indiana University School of Medicine )
Study Sponsor  ICMJE Indiana University School of Medicine
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Kimberly A. Stigler, MD Indiana University School of Medicine
PRS Account Indiana University
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP