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:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT01060150
Eligibility Criteria:
Inclusion Criteria:
* Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for Attention Deficit Hyperactivity Disorder (ADHD) and are considered to require medication therapy
* Participants that agreed to observe visit schedules and willingly complete the evaluation defined by participant (possibly to be completed by parents/guardians) during the treatment period
* Participants and parents/guardians that are able to understand the participation procedures of the research and spontaneously request the discontinuation therein at any time
* Participants that offered spontaneous consent for participation
* Participants whose guardian/legal representative provided spontaneous written consent
Exclusion Criteria:
* Hypersensitivity to methylphenidate HCl
* Participants diagnosed with major depression or anxiety disorders according to DSM-IV Diagnostic criteria and who requires drug therapy
* Participants with a history of bipolar disorder, psychotic disorder, and substance abuse disorder ordiagnosed with an overall developmental disorder, organic brain disorder, seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) disorder, movement disorder requiring the medication therapy, or with a family history of Tourette's syndrome (a neuropsychological disorder that causes marked distress or significant impairment in social, occupational, or other important areas of functioning)
* Taken Osmotic Release Oral System (OROS) Methylphenidate within 3 months prior to screening
* Currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant (drug used to stop seizures) or health food supplements that may have a central nervous system activity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT01060150
Study Brief:
Protocol Section:
NCT01060150