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

Description

The aim of the iSPOT-A study is to:

  • identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and
  • 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 Start Date

October 2009

Estimated Completion Date

July 2017

Interventions

  • Drug: Long Acting Methylphenidate
  • Drug: Short Acting Methylphenidate

Specialties

  • Pediatrics: Basic Science/Genetics,Child/Adolescent Psych,Clinical Pharmacology
  • Psychiatry: Child/Adolescent Psych,Neuro/Psych Pharmacol,Other Psychiatry

MeSH Terms

  • Attention Deficit Disorder with Hyperactivity

Study ID

BRC Operations Pty. Ltd. -- iSPOT-A

Status

Unknown

Trial ID

NCT00863499

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

1344

Sponsor

BRC Operations Pty. Ltd.

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 na've 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.

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Brain Resource Center - Englewood Cliffs, New Jersey 43.3 miles None None None
Brain Resource Center - New York, New York 49.1 miles None None None
Skyland Behavioral Health Associates PA - Ashville, North Carolina 637.2 miles None None None
Shanti Clinical Trials - Colton, California 2,439.7 miles None None None
Center for Healing the Human Spirit - Tarzana, California 2,501.7 miles None None None

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