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

July 9, 2018 updated by: BRC Operations Pty. Ltd.

International Study to Predict Optimised Treatment Response to Short or Long Acting Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder.

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

1344

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Brain Dynamics Centre
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6524 AD
        • Brainclinics Diagnostics B.V.
    • California
      • Colton, California, United States, 92324
        • Shanti Clinical Trials
      • Tarzana, California, United States, 91356
        • Center for Healing the Human Spirit
    • New Jersey
      • Englewood Cliffs, New Jersey, United States, 07632
        • Brain Resource Center
    • New York
      • New York, New York, United States, 10023
        • Brain Resource Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Skyland Behavioral Health Associates , P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
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.
Active Comparator: B
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:
  • *Consider treatment directions above or as physician directed as per usual care.
  • • Concerta
  • • Metadate CD
  • • Methylin ER
  • • Ritalin LA
  • • Ritalin Sustained-Release
No Intervention: C
Healthy Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Barbara A. Cohen, PhD, Center for Healing the Human Spirit
  • Principal Investigator: Harbans Multani, MD, Shanti Clinical Trials
  • Principal Investigator: Martijn Arns, PhD, Brainclinics Diagnostics B.V.
  • Principal Investigator: Roger deBeus, PhD, Skyland Behavioral Health Associates
  • Principal Investigator: Kamran Fallahpour, PhD, Brain Resource Center NY
  • Principal Investigator: Mona Ismail, MD, Brain Resource Center NJ
  • Principal Investigator: Simon Clarke, MD, Brain Dynamics Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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