- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00863499
International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder
International Study to Predict Optimised Treatment Response to Short or Long Acting Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder.
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Brain Dynamics Centre
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6524 AD
- Brainclinics Diagnostics B.V.
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California
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Colton, California, United States, 92324
- Shanti Clinical Trials
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Tarzana, California, United States, 91356
- Center for Healing the Human Spirit
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New Jersey
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Englewood Cliffs, New Jersey, United States, 07632
- Brain Resource Center
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New York
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New York, New York, United States, 10023
- Brain Resource Center
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North Carolina
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Asheville, North Carolina, United States, 28801
- Skyland Behavioral Health Associates , P.A.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: A
Short Acting methylphenidate
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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:
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Active Comparator: B
Long Acting Methylphenidate
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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:
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No Intervention: C
Healthy Controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD.
Time Frame: 6 weeks
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Time Frame: 52 weeks
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52 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara A. Cohen, PhD, Center for Healing the Human Spirit
- Principal Investigator: Harbans Multani, MD, Shanti Clinical Trials
- Principal Investigator: Martijn Arns, PhD, Brainclinics Diagnostics B.V.
- Principal Investigator: Roger deBeus, PhD, Skyland Behavioral Health Associates
- Principal Investigator: Kamran Fallahpour, PhD, Brain Resource Center NY
- Principal Investigator: Mona Ismail, MD, Brain Resource Center NJ
- Principal Investigator: Simon Clarke, MD, Brain Dynamics Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Disease
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- iSPOT-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit/Hyperactivity Disorder
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
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Cingulate TherapeuticsPremier Research Group plcActive, not recruitingADHD | Attention Deficit Hyperactivity Disorder | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Children's National Research InstituteRecruitingADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | ADD | ADHD Predominantly Inattentive Type | ADHD - Combined Type | ADHD, Predominantly Hyperactive - Impulsive | Attention-Deficit Disorder in Adolescence | Attention-Deficit Hyperactivity...United States
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Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
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University Hospital Bispebjerg and FrederiksbergMental Health Services in the Capital Region, DenmarkRecruitingSleep Disturbance | Neurodevelopmental Disorders | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder | Attention-Deficit Hyperactivity Disorder, Unspecified Type | Attention-deficit Hyperactivity | Hyperkinetic Conduct DisorderDenmark
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Corium, Inc.Worldwide Clinical Trials; Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
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Corium, Inc.Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
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Massachusetts General HospitalShire Human Genetic Therapies, Inc.Active, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
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Ataturk UniversityCompletedAttention-deficit/Hyperactivity DisorderTurkey
Clinical Trials on Short Acting Methylphenidate
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Sahlgrenska University Hospital, SwedenCompleted
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Oregon Health and Science UniversityBayer; Merck Sharp & Dohme LLC; Society of Family PlanningTerminated
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Northumbria UniversityCompletedLow Fat Meal - Unadjusted Insulin Dose | High Fat Meal - Unadjusted Insulin Dose | High Fat Meal - Adjusted Insulin Dose +30 Percent | High Fat Meal - Adjusted Insulin Dose +Split Dose
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Lei LiUnknownGynecologic Cancer | Febrile Neutropenia | Chemotherapy-induced Neutropenia | Myelosuppression AdultChina
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Nanjing UniversityUnknownPolycystic Ovary Syndrome | In Vitro FertilizationChina
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Benha UniversityNot yet recruitingDiabetes Mellitus | Corneal Ulcer | Neurotrophic Corneal UlcerEgypt
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Emory UniversityCompletedDiabetes Mellitus | Type 1 DiabetesUnited States
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McGill UniversityCompletedDiabetes Mellitus, Type 1 | Diabete MellitusCanada