OPT - Phase IV Long Term Maintenance Study of Aripiprazole for the Treatment of Irritability Associated With Autistic Disorder
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01227668
First received: October 22, 2010
Last updated: August 14, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to determine whether pediatric subjects with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than subjects treated with placebo
| Condition | Intervention | Phase |
|---|---|---|
|
Autistic Disorder |
Drug: Aripiprazole Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Aripiprazole in the Long-Term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Time from randomization to relapse [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean change from end of Phase 1 to Week 16 endpoint (LOCF) on the Aberrant Behavior Checklist - Irritability Subscale [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]
- Mean Clinical Global Impression - Improvement scale score at Week 16 endpoint (LOCF) [ Time Frame: Every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 215 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Aripiprazole |
Drug: Aripiprazole
Tablets, Oral, 2-15 mg, once daily, 13-42 weeks
Other Names:
|
| Placebo Comparator: Placebo |
Drug: Placebo
Tablets, Oral, 0 mg, once daily, 16 weeks
|
Detailed Description:
Phase 1: Single Blind/ Phase 2: Double Blind
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meets current DSM-IV-TR diagnostic criteria for autistic disorder (confirmed by the ADI-R)
- Demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems
- CGI-S score ≥ 4 AND an ABC Irritability subscale score ≥ 18 at the Screening and Baseline Visits
- Mental age of at least 24 months
Exclusion Criteria:
- Treatment resistance to neuroleptic medication
- Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
- Diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified (NOS), Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder or Fragile X Syndrome
- History of neuroleptic malignant syndrome
- Significant risk of committing suicide
- A seizure within the past year
- History of severe head trauma or stroke
- History or current evidence of any unstable medical conditions
- Weight less than 15 kg
- Known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils
- History of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia
- Any other medically significant abnormal laboratory test result, vital sign result or ECG finding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227668
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Hide Study LocationsLocations
| United States, Alabama | |
| Harmonex Neuroscience Research, Inc | |
| Dothan, Alabama, United States, 36303 | |
| United States, Arizona | |
| Southwest Autism Research And Resource Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Clinical Innovations, Inc. | |
| Costa Mesa, California, United States, 92626 | |
| Behavioral Research Specialists, Llc | |
| Glendale, California, United States, 91206 | |
| Abbey Neuropsychology Clinic | |
| Palo Alto, California, United States, 94306 | |
| Ucsf - Lppi | |
| San Francisco, California, United States, 94143 | |
| Stanford University School Of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, District of Columbia | |
| Children'S National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Sarkis Clinical Trials | |
| Gainesville, Florida, United States, 32607 | |
| Palm Springs Research Institute | |
| Hialeah, Florida, United States, 33012 | |
| Florida Clinical Research Center, Llc | |
| Maitland, Florida, United States, 32751 | |
| Miami Children'S Hospital | |
| Miami, Florida, United States, 33155 | |
| University Of South Florida | |
| Tampa, Florida, United States, 33613 | |
| United States, Georgia | |
| Institute For Behavioral Medicine, Llc | |
| Smyrna, Georgia, United States, 30080 | |
| United States, Idaho | |
| Kootenai Behavioral Health Center | |
| Coeur D'Alene, Idaho, United States, 83814 | |
| United States, Kentucky | |
| Kosair Charities Pediatric Clinical Research Unit | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Lsu Health Sciences Center | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Massachusetts | |
| Neurocare, Inc. | |
| Newton, Massachusetts, United States, 02459 | |
| United States, Michigan | |
| Neurobehavioral Medicine Group | |
| Bloomfield Hills, Michigan, United States, 48302 | |
| United States, Nevada | |
| Center For Psychiatry And Behavioral Medicine, Inc | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Jersey | |
| Clinical Research Center Of New Jersey | |
| Gibbsboro, New Jersey, United States, 08026 | |
| Children'S Specialized Hosp | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New York | |
| Stony Brook University School Of Medicine | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Unc Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27517 | |
| United States, Ohio | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44104 | |
| The Ohio State University Nisonger Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Cutting Edge Research Group | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| Ou Physician'S Child Study Center | |
| Oklahoma City, Oklahoma, United States, 73117 | |
| Tulsa Clinical Research, Llc | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Cyn3rgy Research | |
| Gresham, Oregon, United States, 97030 | |
| United States, Pennsylvania | |
| Drexel University College Of Medicine | |
| Philadelphia, Pennsylvania, United States, 19124 | |
| Western Psychiatric Institute And Clinic | |
| Pittsburgh, Pennsylvania, United States, 15203 | |
| United States, Tennessee | |
| Holston Medical Group | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Insite Clinical Research | |
| Desoto, Texas, United States, 75115 | |
| United States, Utah | |
| Ericksen Research And Development | |
| Clinton, Utah, United States, 84015 | |
| United States, Virginia | |
| Childrens Specialty Gr., Pllc | |
| Norfolk, Virginia, United States, 23510 | |
| Virginia Treatment Center For Children | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01227668 History of Changes |
| Other Study ID Numbers: | CN138-603 |
| Study First Received: | October 22, 2010 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Aripiprazole Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 18, 2013