Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder

NCT ID: NCT01227668

Last Updated: 2014-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-06-30

Brief Summary

The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Detailed Description

Phase 1: Single blind/ Phase 2: Double blind

Conditions

Irritability Associated With Autistic Disorder

Study Design

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

Study Groups

Aripiprazole

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Tablets, Oral, 2-15 mg, once daily, 13-42 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets, Oral, 0 mg, once daily, 16 weeks

Interventions

Aripiprazole

Tablets, Oral, 2-15 mg, once daily, 13-42 weeks

Intervention Type: DRUG

Placebo

Tablets, Oral, 0 mg, once daily, 16 weeks

Intervention Type: DRUG

Other Intervention Names

BMS-337039; Abilify

Eligibility Criteria

Inclusion Criteria

• Male or female children or adolescents, 6 to 17 years of age, inclusive, at the time of the baseline visit
• Meets current diagnostic criteria of the Diagnostic and Statistical Manual-of Mental Disorders IV-Text Revised for autistic disorder and displays behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. Diagnosis of autistic disorder will be confirmed by the Autism Diagnostic Interview-Revised.
• Participant or designated guardian or caregiver is able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
• Demonstrates behaviors such as tantrums, aggression, or self-injury or a combination of these problems
• An Aberrant Behavior Checklist Irritability subscale score ≥18 AND a Clinical Global Impressions Severity score ≥4 at the Screening and Baseline Visits.
• Mental age of at least 24 months

Exclusion Criteria

• Treatment resistant to neuroleptic medication, based on lack of therapeutic response to 2 different neuroleptics after treatment for at least 3 weeks each.
• Previous treatment with aripiprazole for at least 3 weeks duration at an adequate daily dose, without demonstrating a clinically meaningful response.
• Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
• Diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified, Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder, or Fragile X Syndrome
• History of neuroleptic malignant syndrome
• At significant risk for suicide based on history or routine psychiatric status examination
• A seizure within the past year
• History of severe head trauma or stroke
• History or current evidence of any unstable medical conditions that would expose the patient to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
• Weight lower 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 or vital sign result or electrocardiogram finding

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Harmonex Neuroscience Research, Inc

Dothan, Alabama, United States

Southwest Autism Research And Resource Center

Phoenix, Arizona, United States

Clinical Innovations, Inc.

Costa Mesa, California, United States

Behavioral Research Specialists, Llc

Glendale, California, United States

Abbey Neuropsychology Clinic

Palo Alto, California, United States

Ucsf - Lppi

San Francisco, California, United States

Stanford University School Of Medicine

Stanford, California, United States

Children'S National Medical Center

Washington D.C., District of Columbia, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Palm Springs Research Institute

Hialeah, Florida, United States

Florida Clinical Research Center, Llc

Maitland, Florida, United States

Miami Children'S Hospital

Miami, Florida, United States

University Of South Florida

Tampa, Florida, United States

Institute For Behavioral Medicine, Llc

Smyrna, Georgia, United States

Kootenai Behavioral Health Center

Coeur d'Alene, Idaho, United States

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, United States

Lsu Health Sciences Center

Shreveport, Louisiana, United States

Neurocare, Inc.

Newton, Massachusetts, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Center For Psychiatry And Behavioral Medicine, Inc

Las Vegas, Nevada, United States

Clinical Research Center Of New Jersey

Gibbsboro, New Jersey, United States

Children'S Specialized Hosp

Toms River, New Jersey, United States

Stony Brook University School Of Medicine

Stony Brook, New York, United States

Unc Chapel Hill

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

The Ohio State University Nisonger Center

Columbus, Ohio, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Ou Physician'S Child Study Center

Oklahoma City, Oklahoma, United States

Tulsa Clinical Research, Llc

Tulsa, Oklahoma, United States

Cyn3rgy Research

Gresham, Oregon, United States

Drexel University College Of Medicine

Philadelphia, Pennsylvania, United States

Western Psychiatric Institute And Clinic

Pittsburgh, Pennsylvania, United States

Holston Medical Group

Kingsport, Tennessee, United States

Insite Clinical Research

DeSoto, Texas, United States

Ericksen Research And Development

Clinton, Utah, United States

Childrens Specialty Gr., Pllc

Norfolk, Virginia, United States

Virginia Treatment Center For Children

Richmond, Virginia, United States

Countries

United States

References

Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Findling RL, Mankoski R, Timko K, Lears K, McCartney T, McQuade RD, Eudicone JM, Amatniek J, Marcus RN, Sheehan JJ. A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder. J Clin Psychiatry. 2014 Jan;75(1):22-30. doi: 10.4088/jcp.13m08500.

Reference Type: DERIVED

PMID: 24502859 (View on PubMed)

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CN138-603

Identifier Type: -

Identifier Source: org_study_id