| May 31, 2006 |
| June 3, 2009 |
| June 2006 |
| April 2008 (final data collection date for primary outcome measure) |
| Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ] |
| Change in an irritability score |
| Complete list of historical versions of study NCT00332241 on ClinicalTrials.gov Archive Site |
- Mean Clinical Global Impressions Improvement Scale (CGI-I) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
- Number of Participants With Response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
- Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
- Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
- Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
- Summary of Safety [ Time Frame: continuous throughout the study ] [ Designated as safety issue: Yes ]
- Change From Baseline in Body Weight [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
|
| Changes in clinical global impression, Changes in checklist for aberrant behavior, other sub-scales and the response rate, Reduction in compulsive behavior, Compare tolerability and safety of aripiprazole with placebo |
| |
| Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD) |
| A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD) |
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD). |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Autistic Disorder |
- Drug: Aripiprazole
- Drug: Placebo
|
| Experimental: Active Abilify |
| |
| |
| Completed |
| 98 |
| April 2008 |
| April 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Meets current Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems. Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)
- CGI score > = 4 AND and Aberrant Behavior Checklist (ABC) Irritability/Agitation subscale score > = 18 at screening and baseline (randomization)
- Mental age of at least 18 months
- Male or female 6 to 17 years of age, inclusive, at the time of randomization
Exclusion Criteria:
- Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each.
- Patients previously treated and not responding to aripiprazole treatment
- The patient is currently diagnosed with another disorder on the autism spectrum, including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
- Current diagnosis of bipolar disorder, psychosis, or schizophrenia, or major depression
- A seizure in the past year
- History of severe head trauma or stroke
- Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral modification) must have started at least 2 months prior to the initial screening visit and must remain in a consistent treatment program for the duration of the study.
|
| Both |
| 6 Years to 17 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00332241 |
| Study Director, Bristol-Myers Squibb |
| CN138-178 |
| Bristol-Myers Squibb |
| Otsuka America Pharmaceutical |
| Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
|
|
| Bristol-Myers Squibb |
| June 2009 |