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Trial record 14 of 405 for:    ARIPIPRAZOLE

Study to Evaluate the Efficacy and Safety of Aripiprazole

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02069977
Recruitment Status : Unknown
Verified March 2014 by Yoo-Sook Joung, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : February 24, 2014
Last Update Posted : March 11, 2014
Sponsor:
Collaborator:
Korea Otsuka International Asia Arab
Information provided by (Responsible Party):
Yoo-Sook Joung, Samsung Medical Center

Brief Summary:
  • To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder, as measured by change from baseline to endpoint on the irritability subscale of the aberrant behavior checklist (ABC-I).
  • To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the treatment of serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder.

Condition or disease Intervention/treatment Phase
Autism Drug: Aripiprazole Phase 4

Detailed Description:

1. Study design

- Multi-national, Multi-center, 52 weeks open label, single arm design


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Aripiprazole in Asian Pediatric Patients With Autism Spectrum Disorder and Behavior Problems
Study Start Date : February 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aripiprazole
  • Dose level: 2, 5, 10, 15 mg/day
  • Starting dose: 2 mg/day
  • Dose increment: The dose should be gradually increased according to the investigator's judgment of subject's response.
  • Target dose: 5-15 mg/day
  • Maximum dose: 15 mg/day
  • Flexibly dosed (2 to 15 mg/day) aripiprazole (oral tablet or solution) is taken once in a day at the same time without regarding to meals
Drug: Aripiprazole
Other Name: Abilify®




Primary Outcome Measures :
  1. irritability subscale of the aberrant behavior checklist [ Time Frame: Week 12 ]

    Mean change from baseline to endpoint of Part 1 (week 12)in the caregiver-rated ABC Irritability (ABC-I) subscale score.

    ABC Scale will be completed by subject



Secondary Outcome Measures :
  1. Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 52 ]
    ABC Scale will be completed by subject

  2. Change of CGI-S, CGI-I from baseline [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 52 ]
    CGI-S, CGI-I scale will be evaluated by investigator

  3. Change of Behavioral problems from baseline [ Time Frame: Week 12, 52 ]
    Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)

  4. Change of Adaptive Skills from baseline [ Time Frame: week 12, 52 ]
    Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS)

  5. Change of Parental stress from baseline [ Time Frame: Weekk 12, 52 ]
    Parental stress scale: Parenting Stress Index (PSI)


Other Outcome Measures:
  1. Adverse events (AEs) [ Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 52 ]

    Safety will be evaluated based on below inormaiton.

    • Laboratory test results (routine lab. and serum prolactin)
    • Vital signs (blood pressure, pulse, body temperature)
    • ECG
    • Weight gain
    • Extrapyramidal side effects (EPSEs) assessed by Simpson-Angus Rating Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS)



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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:

  • 6 to 17 years of age.
  • Meeting the diagnostic criteria for autistic disorder specified by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), with a diagnosis corroborated by the Autism Diagnostic Interview-Revised (ADI-R) diagnostic instrument and demonstrated behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these.
  • Clinical Global Impressions (CGI) Severity subscale score ≥ 4 at screening and baseline.
  • Aberrant Behavior Checklist (ABC) Irritability subscale score ≥18 at screening and baseline.
  • Mental age ≥ 18 months.
  • Women of childbearing potential (WOCBP) have to use an adequate method of contraception
  • WOCBP must have had a negative serum or urine pregnancy test.
  • The patient and/or the designated guardian(s) or caregiver(s) who are able to comprehend and comply with the protocol requirements, in the opinion of the investigator and have consented to participate by signing an informed consent form.

Exclusion Criteria:

  • Current diagnosis of bipolar disorder, schizophrenia, major depressive disorder, Rett's disorder, or Fragile-X syndrome.
  • History of neuroleptic malignant syndrome.
  • Significant risk of committing suicide based on history or routine psychiatric status examination.
  • History of seizure in the past 1 year.
  • History of severe head trauma or stroke
  • History or current evidence of any unstable medical conditions
  • Patient considered treatment resistant to neuroleptic medication
  • Patient considered treatment resistant to aripiprazole
  • Woman who is pregnant or breastfeeding
  • ECG: QTc > 475 msec
  • Platelets ≤ 75,000/μL
  • Hemoglobin ≤ 9 g/dL
  • Neutrophils ≤ 1.0x10^3/μL
  • Aspartate or alanine transaminase (AST or ALT) > 3xULN
  • Serum creatinine ≥ 2 mg/dL
  • Patient weighed < 15 kg
  • Patient who participated in any other clinical trial within 4 weeks
  • Patient determined to require the administration of the prohibited medications during the study period
  • Patient with other conditions determined by the investigator to be inappropriate for this clinical study

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): NCT02069977


Contacts
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Contact: Hyemi Cheon 82-70-4033-3059 cheon.hyemi@cnrres.co.kr

Locations
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Korea, Republic of
Inje University Ilsan Paik Hospital Recruiting
Ilsan, Gyeonggi-do, Korea, Republic of, 411-706
Principal Investigator: Eun-Jin Park, MD, PhD.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Principal Investigator: Yoo-Sook Joung, MD., PhD.         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 138-736
Principal Investigator: Hyo-Won Kim, MD,PhD         
Philippines
Medical City Not yet recruiting
Pasig, Philippines
Principal Investigator: Stella Manalo, MD         
Philippine Children's Medical Center Not yet recruiting
Quezon City, Philippines
Principal Investigator: Alexis Reyes, MD         
Thailand
Siriraj Hospital Mahidol University Not yet recruiting
Bangkok, Thailand, 10700
Principal Investigator: Vitharon Boon-yasidhi, MD         
Sponsors and Collaborators
Yoo-Sook Joung
Korea Otsuka International Asia Arab
Investigators
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Principal Investigator: Yoo-Sook Joung, MD. PhD. Sumsung Medical Center

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Responsible Party: Yoo-Sook Joung, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02069977     History of Changes
Other Study ID Numbers: 031OTC1301
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Yoo-Sook Joung, Samsung Medical Center:
Autism
Aripiprazole
Abilify

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