A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

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ClinicalTrials.gov Identifier: NCT01617460

Recruitment Status : Completed

First Posted : June 12, 2012

Results First Posted : October 20, 2017

Last Update Posted : October 20, 2017

Sponsor:

Information provided by (Responsible Party):

Otsuka Pharmaceutical Co., Ltd.

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Autistic Disorder	Drug: Aripiprazole	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	86 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Long-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Study Start Date :	September 2012
Actual Primary Completion Date :	October 2016
Actual Study Completion Date :	October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aripiprazole

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aripiprazole administered orally once daily	Drug: Aripiprazole Flexibly dose administered orally once daily

Outcome Measures

Primary Outcome Measures :

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 ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617460

Locations

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Japan

Chubu Region, Japan

Chugoku Region, Japan

Kanto Region, Japan

Kinki Region, Japan

Kyushu Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

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Study Director:	Hiroaki Ono, Mr	Otsuka Pharmaceutical Co., Ltd.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ichikawa H, Hiratani M, Yasuhara A, Tsujii N, Oshimo T, Ono H, Tadori Y. An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan. Psychiatry Clin Neurosci. 2018 Feb;72(2):84-94. doi: 10.1111/pcn.12607. Epub 2017 Nov 8.

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Responsible Party:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01617460
Other Study ID Numbers:	031-11-003
First Posted:	June 12, 2012 Key Record Dates
Results First Posted:	October 20, 2017
Last Update Posted:	October 20, 2017
Last Verified:	May 2017

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:


Autistic Disorder, children and adolescents aripiprazole Long-term safety study children and adolescents

Additional relevant MeSH terms:

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Disease Autistic Disorder Pathologic Processes Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Aripiprazole Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants	Physiological Effects of Drugs Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Dopamine D2 Receptor Antagonists Dopamine Antagonists

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