Clinical trial NCT00863499: International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: Attention Deficit/Hyperactivity Disorder
Attention Deficit Disorder
ADHD
ADD
iSPOT
Lead sponsor: BRC Operations Pty. Ltd.
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 1344
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD.
timeFrame: 6 weeks
Secondary outcomes:
measure: To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Colton
country: United States
facility: Shanti Clinical Trials
state: California
city: Tarzana
country: United States
facility: Center for Healing the Human Spirit
state: California
city: Englewood Cliffs
country: United States
facility: Brain Resource Center
state: New Jersey
city: New York
country: United States
facility: Brain Resource Center
state: New York
city: Asheville
country: United States
facility: Skyland Behavioral Health Associates , P.A.
state: North Carolina
city: Westmead
country: Australia
facility: Brain Dynamics Centre
state: New South Wales
city: Nijmegen
country: Netherlands
facility: Brainclinics Diagnostics B.V.
state: Gelderland
Study officials:
affiliation: Center for Healing the Human Spirit
name: Barbara A. Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanti Clinical Trials
name: Harbans Multani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brain Resource Center NY
name: Kamran Fallahpour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brainclinics Diagnostics B.V.
name: Martijn Arns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brain Resource Center NJ
name: Mona Ismail, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skyland Behavioral Health Associates
name: Roger deBeus, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brain Dynamics Centre
name: Simon Clarke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arns M, Vollebregt MA, Palmer D, Spooner C, Gordon E, Kohn M, Clarke S, Elliott GR, Buitelaar JK. Electroencephalographic biomarkers as predictors of methylphenidate response in attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2018 Aug;28(8):881-891. doi: 10.1016/j.euroneuro.2018.06.002. Epub 2018 Jun 22.