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International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder

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: NCT00863499
Recruitment Status : Unknown
Verified July 2018 by BRC Operations Pty. Ltd..
Recruitment status was:  Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
BRC Operations Pty. Ltd.

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 18, 2009
Last Update Posted Date July 11, 2018
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD. [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in ADHD [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder
Official Title  ICMJE International Study to Predict Optimised Treatment Response to Short or Long Acting Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder.
Brief Summary

The aim of the iSPOT-A study is to:

  1. identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and
  2. identify brain, genetic and cognitive markers that predict treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder.
Detailed Description

This is a multi-center, open-label effectiveness trial to identify objective indicators of treatment response in ADHD subjects (versus healthy controls) using cognitive and brain function measures, brain structure and genetic measures in subjects diagnosed with ADHD.

At least 672 naïve and treatment experienced subjects with ADHD will be enrolled from approximately 10 primary care centers. These patients are to be outpatients.

In addition, up to 672 healthy (non-ADHD) control subjects will be recruited who match the enrolled ADHD subjects in race, age, gender and years of education.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Attention Deficit/Hyperactivity Disorder
Intervention  ICMJE
  • Drug: Short Acting Methylphenidate
    Dosage: 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.
    Other Names:
    • • Ritalin
    • • Ritalina
    • • Attenta
    • • Methylin
    • • Penid
    • • Rubifen
    • *Consider treatment directions above or as physician directed as per usual care.
  • Drug: Long Acting Methylphenidate
    Dosage: 9 to 20 mg once daily in the morning (with or without food) with gradual increments of 9 to 20 mg weekly. Daily dosage above 60 mg is not recommended.
    Other Names:
    • • Concerta
    • • Metadate CD
    • • Methylin ER
    • • Ritalin LA
    • • Ritalin Sustained-Release
    • *Consider treatment directions above or as physician directed as per usual care.
Study Arms  ICMJE
  • Active Comparator: A
    Short Acting methylphenidate
    Intervention: Drug: Short Acting Methylphenidate
  • Active Comparator: B
    Long Acting Methylphenidate
    Intervention: Drug: Long Acting Methylphenidate
  • No Intervention: C
    Healthy Controls
Publications * Arns M, Vollebregt MA, Palmer D, Spooner C, Gordon E, Kohn M, Clarke S, Elliott GR, Buitelaar JK. Electroencephalographic biomarkers as predictors of methylphenidate response in attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2018 Aug;28(8):881-891. doi: 10.1016/j.euroneuro.2018.06.002. Epub 2018 Jun 22.

*   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: March 17, 2009)
1344
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have signed an informed consent or assent form where required and/or whose parent or legal guardian has provided written informed consent.
  • Subjects who meet DSM-IV criteria for primary diagnosis of ADHD at study entry, as determined by a psychiatrist, physician or clinical psychologist in conjunction with the clinical work-up undertaken by trained research assistants, as defined by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
  • Subjects who score at least 6 Inattentive or Hyperactive/impulsive items >1 on the Attention Deficit / Hyperactivity Disorder Rating Scale.
  • Subjects who are stimulant naïve or stimulant free (defined as no stimulant medication in the previous 7 days*).
  • Subjects who are 6-17 years of age (with an emphasis to enrol at least a third of the subjects who are ≥ 13 years of age).
  • Subjects who are fluent and literate in English (and/or Dutch in The Netherlands).

    • coming off the stimulant medication for 7 days may place the participant at increased risk, therefore, the participant may have this washout period reduced to that defined in the drug package insert or 5 times the medication half life.

Exclusion Criteria:

  • Known contra-indication or intolerance to the use of methylphenidate as defined in the product package insert (including previous treatment failure at the highest recommended dose).
  • Pregnancy and females of child bearing potential who are not using a form of contraception and are at risk of becoming pregnant during the study.
  • Known medical condition, disease or neurological disorder which might, in the opinion of investigator/s, interfere with the assessments to be made in the study or put ADHD patients at increased risk when exposed to optimal doses of the drug treatment. For example, a diagnosis of epilepsy would exclude a patient from this trial.
  • History of physical brain injury or blow to the head that resulted in loss of consciousness for at least 10 minutes or at least 5minutes within the last two years. Prior treatment with methylphenidate or any other stimulant medication in the past 7 days.
  • Known past or present substance dependence, including alcohol, as determined by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
  • Participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study.
  • Use of any psychological or counselling therapy or CNS medication that cannot be washed out prior to participation or use of any psychological or counselling therapy between the baseline and week 6 (or Early Termination) visits.
  • Subjects who, in the opinion of the investigator, have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere with their ability to complete the testing batteries.
  • Subjects who, in the opinion of the investigator, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
  • Presence of any other co-morbid primary DSM IV disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Netherlands,   United States
Removed Location Countries New Zealand,   South Africa
 
Administrative Information
NCT Number  ICMJE NCT00863499
Other Study ID Numbers  ICMJE iSPOT-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BRC Operations Pty. Ltd.
Study Sponsor  ICMJE BRC Operations Pty. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara A. Cohen, PhD Center for Healing the Human Spirit
Principal Investigator: Harbans Multani, MD Shanti Clinical Trials
Principal Investigator: Kamran Fallahpour, PhD Brain Resource Center NY
Principal Investigator: Martijn Arns, PhD Brainclinics Diagnostics B.V.
Principal Investigator: Mona Ismail, MD Brain Resource Center NJ
Principal Investigator: Roger deBeus, PhD Skyland Behavioral Health Associates
Principal Investigator: Simon Clarke, MD Brain Dynamics Centre
PRS Account BRC Operations Pty. Ltd.
Verification Date July 2018

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