- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01617460
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
May 29, 2017 updated by: Otsuka Pharmaceutical Co., Ltd.
A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
Study Overview
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chubu Region, Japan
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Chugoku Region, Japan
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Kanto Region, Japan
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Kinki Region, Japan
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Kyushu Region, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.
- The patient has completed the 031-11-002 study (the patient has visited the hospital during week8)
- Inpatient or outpatient status
Exclusion Criteria:
- The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
- Patients who fall under a contraindication listed in the ABILIFY package insert
- Others
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Aripiprazole
administered orally once daily
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Flexibly dose administered orally once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score
Time Frame: Baseline, the final administration
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The ABC-J Irritability subscale consists of 15 items.
Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior.
Individual scores were summed, therefore, the overall score range was between 0-45.
Higher scores represent worse condition.
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Baseline, the final administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
June 8, 2012
First Submitted That Met QC Criteria
June 11, 2012
First Posted (Estimate)
June 12, 2012
Study Record Updates
Last Update Posted (Actual)
October 20, 2017
Last Update Submitted That Met QC Criteria
May 29, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Autism Spectrum Disorder
- Disease
- Autistic Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- 031-11-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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