Predict Optimised Treatment in 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.
ADHD Research Study
Study Type: 
ADHD Research Study - Phase IV
Study Design: 

Allocation; Non-Randomized

Intervention Model:  Parallel Assignment

Masking:  Open Label

Primary Purpose:  Health Services Research

Primary Outcome Measures: 

To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' 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}

1344 (estimated)
Study Start Date: 
June 2009
Primary Completion Date: 
July 2012
  • Active-Comparator:  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.
  • No Intervention:  Healthy matched controls
Assigned Interventions: 

Short-acting methylphenidate (Ritalin)

Ages of Eligibility: 
Ages 6 to 17
Inclusion Criteria: 

Inclusion Criteria:

  • Meet DSM-IV criteria for primary diagnosis of ADHD at study entry, as determined by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
  • Have an Attention Deficit / Hyperactivity Disorder Rating Scale (ADHD-RS IV) score ≥6 for inattention and/or hyperactivity-impulsivity.
  • Subject is a candidate for methylphenidate.
  • Stimulant naïve or stimulant free (defined as no stimulant medication in the previous 7 days).
  • Males and females 6-17 years of age (with an emphasis to enroll at least a third of the subjects who are ≥ 13 years of age).
  • Subjects who are fluent and literate in English or Dutch (the languages in which the psychological assessments have been validated).
  • Subjects who have signed an informed consent or assent form where required and/or whose parent or legal guardian has provided written informed consent.


Exclusion Criteria: 

Exclusion Criteria:

  • Known contra-indication to the use of methylphenidate.
  • 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 (including, but not limited to, anxiety, tension or agitation; glaucoma; motor tics; family history or diagnosis of Tourette's syndrome; treatment with monoamine oxidase inhibitors, and within 14 days following discontinuation of monoamine oxidase inhibitors; serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug; hypertension, heart failure, recent myocardial infarction, ventricular arrhythmia; psychotic disorder, bipolar disorder, family history of suicide, bipolar disorder and depression; prior history of seizures or prior EEG abnormalities; allergy to any of the inactive ingredients in Ritalin).
  • History of physical brain injury or blow to the head that resulted in loss of consciousness of greater than 5 minutes.
  • 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 (excluding follow-up studies in which the test drug/device has been registered in a major market) in which subjects have received an experimental drug/device that could affect the primary end points of this study.
  • 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 (other than conduct disorder or oppositional defiant disorder).
  • Known history of hypersensitivity and/or anaphylaxis to methylphenidate.



Dr. Barbara A. Cohen, Ph.D., MFT

Center for Healing the Human Spirit Recruiting
Tarzana, California, United States, 91356
Contact: Barbara A. Cohen, PhD     818-343-1331    
Principal Investigator: Barbara A. Cohen, PhD    


Tarzana, CA

Sponsors & Collaborators: 

BRC Operations Pty. Ltd.

United States, California
Center for Healing the Human Spirit - Recruiting
Tarzana, California, United States, 91356
Contact:  Barbara A. Cohen, Ph.D.   818-343-1331
Principal Investigator:  Barbara A. Cohen, Ph.D.
Shanti Clinical Trials - Recruiting
Colton, California, United States, 92324
Contact:  Nitin Rastogi   909-423-0367
Principal Investigator:  Gurmeet Multani, MD
United States, North Carolina
Skyland Behavioral Health Associates, P.A. - Recruiting
Ashville, North Carolina, United States, 28801
Contact:  Roger deBeus, Ph.D.   828-252-2501
Principal Investigator:  Roger deBeus, Ph.D.
Netherlands, Gelderland
Brainclinics Diagnostics B.V. - Recruiting
Nijmegen, Gelderland, Netherlands, 6524 AD
Contact:  Desiree Spronk   +31(0)24 750 3509
Principal Investigator:  Martijn Arns, Ph.D.
Study ID Numbers: 

Center for Healing the Human Spirit, Tarzana, CA

Earn up to $135 by helping researchers!

International researchers need healthy participants for an ADHD Research Study. You can   participate if you are ages 6 to 17, do not have ADHD, have never taken stimulant medication, and meet the full criteria of this Study. Participation involves a phone pre-screening, two on-site visits, clinical assessments, and follow up interviews. Participation in this study is completely confidential.
Call: 818-343-1331.  Visit us at:  Email:

Do you have a child ages 6 to 17 with ADHD?  Or think your child might have ADHD?

Help international researchers discover ways to make treatment for ADHD with FDA approved medication more effective.  You will receive personalized information about your child's ADHD treatment with medication. You can participate if you are age 6 to 17, have ADHD, can take       short-acting methylphenidate (Ritalin), and meet the full criteria of this Study.  Participation   involves a phone pre-screening, two on-site visits, clinical assessments, medication treatment      with your existing doctor, and follow up interviews. Participation in this study is completely confidential.  You may be compensated up to $135.                                                                                                                                                                   Call: 818-343-1331.    Visit us at:   Email: