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Trial record 100 of 405 for:    ARIPIPRAZOLE

Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03179787
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment
Autism Drug: Aripiprazole oral product

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Aripiprazole oral product
    oral administration of aripiprazole


Primary Outcome Measures :
  1. aberrant behavior checklist [ Time Frame: 12 months ]
    change from baseline to 12 month



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
Sampling Method:   Non-Probability Sample
Study Population
naive patients with aripiprasole
Criteria

Inclusion Criteria:

  • diagnosed as autism with irritability

Exclusion Criteria:

  • patients who has ever been treated with aripiprazole

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): NCT03179787


Contacts
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Contact: Drug Information Center +81-3-6361-7314 yasudam@otsuka.jp

Locations
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Japan
Tokai Univ. Recruiting
Isehara, Japan
Contact: Katsuhiro Mikami, MD         
Tokai Univ. Recruiting
Isehara, Japan
Contact: Katsunaka Mikami, MD         
Recruiting
Kanto Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Jean-David Rafizadeh-Kabe Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03179787     History of Changes
Other Study ID Numbers: 031-101-00116
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
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Aripiprazole
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
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