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| Sponsor: | BRC Operations Pty. Ltd. |
|---|---|
| Information provided by (Responsible Party): | BRC Operations Pty. Ltd. |
| ClinicalTrials.gov Identifier: | NCT00863499 |
Purpose
The aim of the iSPOT-A study is to:
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit/Hyperactivity Disorder |
Drug: Short Acting Methylphenidate Drug: Long Acting Methylphenidate |
Phase IV |
| 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. |
| Estimated Enrollment: | 1344 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (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:
|
|
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:
|
|
No Intervention: C
Healthy Controls
|
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 |
Inclusion Criteria:
Subjects who are fluent and literate in English (and/or Dutch in The Netherlands).
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Shanti Clinical Trials | Recruiting |
| Colton, California, United States, 92324 | |
| Contact: Nitin Rastogi 909-423-0367 rasnitin@yahoo.com | |
| Principal Investigator: Harbans Multani, MD | |
| 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 | Recruiting |
| New York, New York, United States, 10023 | |
| Contact: Julia Yakovlova 212-877-2130 jy@brainresourcecenter.com | |
| Principal Investigator: Kamran Fallahpour, PhD | |
| 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: Niels Veth, PhD +31 (0) 24 750 3509 cpmveth@brainclinics.com | |
| Principal Investigator: Martijn Arns, PhD | |
| 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
| 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: | January 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Attention Deficit/Hyperactivity Disorder Attention Deficit Disorder ADHD ADD iSPOT |
|
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 |