Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00573534
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV-TR criteria for ADHD
* Has a Gender-Matched older sibling with ADHD and substance dependence
* Medically healthy
* Parents give informed consent
* Child gives assent
Exclusion Criteria:
* Significant use of alcohol or marijuana (more than ten episodes) in the past 30 days or any use of cocaine or opiates in the past 30 days; significant nicotine use is not an exclusion
* History of cardiac abnormality, past cardiac problems or family history of the same, history of fainting, open-heart surgery, and arrhythmia
* History of paranoia on stimulant medication
* Seizure or other neurological disturbance
* Pregnancy
* Moderate to severe mental deficiency as determined by IQ \<60 or placement in special education for mental deficiency
* Physical exam or laboratory results with significant abnormalities
* Active suicidal or homicidal ideation or history of suicide attempts
* Unequivocal manic or hypomanic episode
* Sexually active females who are unwilling to use effective methods of contraception
* Psychosis or psychosis in a first degree relative
* Current Major Depression
* Individuals who have previously seen a cardiologist until reevaluated by a cardiologist
* Individuals for whom the current cardiac evaluation is not definitive until seen by a cardiologist and given an echocardiogram
* Individuals with Tic disorder
* Significant co-morbid anxiety disorders (i.e., OCD, Panic, PTSD)
* ADHD in remission on another psychostimulant or not in remission but in the context of inadequate dosing of a currently prescribed and administered other psychostimulant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
15 Years
Study:
NCT00573534
Study Brief:
Protocol Section:
NCT00573534