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

This study is currently recruiting participants.
Verified October 2013 by BRC Operations Pty. Ltd.
Sponsor:
Information provided by (Responsible Party):
BRC Operations Pty. Ltd.
ClinicalTrials.gov Identifier:
NCT00863499
First received: March 17, 2009
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention Phase
Attention Deficit/Hyperactivity Disorder
Drug: Short Acting Methylphenidate
Drug: Long Acting Methylphenidate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: International Study to Predict Optimised Treatment Response to Short or Long Acting Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder.

Resource links provided by NLM:


Further study details as provided by BRC Operations Pty. Ltd.:

Primary Outcome Measures:
  • To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1344
Study Start Date: October 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Short-acting methylphenidate
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.
Active Comparator: B
Long Acting Methylphenidate
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.
No Intervention: C
Healthy Controls

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863499

Locations
United States, California
Shanti Clinical Trials Active, not recruiting
Colton, California, United States, 92324
Center for Healing the Human Spirit Recruiting
Tarzana, California, United States, 91356
Contact: Barbara A. Cohen, PhD    818-343-1331    drbarbara@healingthehumanspirit.com   
Principal Investigator: Barbara A. Cohen, PhD         
United States, New Jersey
Brain Resource Center Completed
Englewood Cliffs, New Jersey, United States, 07632
United States, New York
Brain Resource Center Active, not recruiting
New York, New York, United States, 10023
United States, North Carolina
Skyland Behavioral Health Associates , P.A. Completed
Ashville, North Carolina, United States, 28801
Australia, New South Wales
Brain Dynamics Centre Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Tracey Tsang, PhD    +61 2 9845 8161    tracey.tsang@sydney.edu.au   
Principal Investigator: Simon Clarke, MD         
Netherlands
Brainclinics Diagnostics B.V. Recruiting
Nijmegen, Gelderland, Netherlands, 6524 AD
Contact: Rik van Dinteren       rik@brainclinics.com   
Principal Investigator: Martijn Arns, PhD         
Sponsors and Collaborators
BRC Operations Pty. Ltd.
Investigators
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
  More Information

No publications provided

Responsible Party: BRC Operations Pty. Ltd.
ClinicalTrials.gov Identifier: NCT00863499     History of Changes
Other Study ID Numbers: iSPOT-A
Study First Received: March 17, 2009
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by BRC Operations Pty. Ltd.:
Attention Deficit/Hyperactivity Disorder
Attention Deficit Disorder
ADHD
ADD
iSPOT

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014