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

NCT01617460 | Completed Phase 3 Results

• 1 other identifier: 031-11-003
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 5

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).

Conditions

Autistic Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score

  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.

  Baseline, the final administration

Study Arms (1)

Aripiprazole

EXPERIMENTAL

administered orally once daily

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Flexibly dose administered orally once daily

Aripiprazole

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Related Publications (1)

• 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.

  PMID: 28941259 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

+81-3-6361-7366

Study Officials

• Hiroaki Ono, Mr

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 6, 2024
• Results First Posted: October 20, 2017

Record last verified: 2024-08

Locations

JP (5)