International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder
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|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
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder||Drug: Short Acting Methylphenidate Drug: Long Acting Methylphenidate||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||1344 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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.|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
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.
No Intervention: C
- To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD. [ Time Frame: 6 weeks ]
- To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863499
|United States, California|
|Shanti Clinical Trials|
|Colton, California, United States, 92324|
|Center for Healing the Human Spirit|
|Tarzana, California, United States, 91356|
|United States, New Jersey|
|Brain Resource Center|
|Englewood Cliffs, New Jersey, United States, 07632|
|United States, New York|
|Brain Resource Center|
|New York, New York, United States, 10023|
|United States, North Carolina|
|Skyland Behavioral Health Associates , P.A.|
|Asheville, North Carolina, United States, 28801|
|Australia, New South Wales|
|Brain Dynamics Centre|
|Westmead, New South Wales, Australia, 2145|
|Brainclinics Diagnostics B.V.|
|Nijmegen, Gelderland, Netherlands, 6524 AD|
|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|