Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism


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Verified June 2017 by Otsuka Pharmaceutical Co., Ltd.

Sponsor:

Information provided by (Responsible Party):

Otsuka Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03179787

First received: June 1, 2017

Last updated: June 6, 2017

Last verified: June 2017

The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.

Autism Drug: Aripiprazole oral product

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

Primary Outcome Measures:

Estimated Enrollment: 300
Actual Study Start Date: April 1, 2017
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Intervention Details:

Drug: Aripiprazole oral product

oral administration of aripiprazole

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

naive patients with aripiprasole

Inclusion Criteria:

  • diagnosed as autism with irritability

Exclusion Criteria:

  • patients who has ever been treated with aripiprazole

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03179787

Tokai Univ.
Isehara, Japan
Contact: Katsuhiro Mikami, MD         
Tokai Univ.
Isehara, Japan
Contact: Katsunaka Mikami, MD         
Kanto Region, Japan

Otsuka Pharmaceutical Co., Ltd.

Study Director: Jean-David Rafizadeh-Kabe Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03179787     History of Changes
Other Study ID Numbers: 031-101-00116
Study First Received: June 1, 2017
Last Updated: June 6, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 07, 2017