International Study to Predict Optimized Treatment - in Attention-Deficit and Hyperactivity Disorder - iSPOT-A

Phase 1

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: EUCTR2009-013272-47-NL
• Lead Sponsor: BRC operations Pty. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-21
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 722

Inclusion Criteria

Inclusion Criteria for ADHD Subjects
• 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 of 6 or higher 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
• 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.

Inclusion Criteria for Control Subjects
• Male and females 6-17 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria for ADHD Subjects
• 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.

Exclusion Criteria for Control Subjects
• Current or previous diagnosis of ADHD or any other psychiatric diagnosis.
• 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 subjects at increased risk (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, ventricu

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of the iSPOT-A trial are to use Brain Resource's standardized 'Integrative Neuroscience' test batteries to 1) Identify objective markers of ADHD compared with healthy controls, using cognitive, brain and genetic markers<br>2) Identify objective markers that best predict treatment response (defined by active symptom remission) to methylphenidate (immediate release formulation) using cognitive, brain and genetic markers.;Secondary Objective: ;Primary end point(s): The primary aim of this study is to establish objective and reliable markers for diagnosis and treatment evaluation. To this aim, treatment response will not simply be measured by change in clinical rating (e.g. Conners), but also through normalization (change from outside to within normal range) of baseline differences in markers. As a complement to previous research using clinical symptoms, markers that improve concurrently with clinical symptoms will be identified through correlation analyses.