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Trial record 15 of 411 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

Tracking Information
First Submitted Date  ICMJE February 13, 2014
First Posted Date  ICMJE February 24, 2014
Last Update Posted Date March 11, 2014
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
  • 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
  • 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
  • Change of Behavioral problems from baseline [ Time Frame: Week 12, 52 ]
    Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
  • Change of Adaptive Skills from baseline [ Time Frame: week 12, 52 ]
    Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS)
  • Change of Parental stress from baseline [ Time Frame: Weekk 12, 52 ]
    Parental stress scale: Parenting Stress Index (PSI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 20, 2014)
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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Aripiprazole
Official Title  ICMJE 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
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.
Detailed Description

1. Study design

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE Drug: Aripiprazole
Other Name: Abilify®
Study Arms  ICMJE 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
Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 20, 2014)
79
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Philippines,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02069977
Other Study ID Numbers  ICMJE 031OTC1301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yoo-Sook Joung, Samsung Medical Center
Study Sponsor  ICMJE Yoo-Sook Joung
Collaborators  ICMJE Korea Otsuka International Asia Arab
Investigators  ICMJE
Principal Investigator: Yoo-Sook Joung, MD. PhD. Sumsung Medical Center
PRS Account Samsung Medical Center
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP