Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
6–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female subjects aged 6-12 years, inclusive.
Subjects meeting the DSM-IV criteria for ADHD of any type, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to screening visit (Concerta® 36 mg and 54 mg is allowable)
You may not be if
Parent or guardian unable or unwilling to complete the Conner's ADHD/DSM-IV Scale for Parents (CADS-P) and the Daily Diary Card
Diagnosed with a tic disorder or Tourette's syndrome
History of seizure disorder
The presence of a known medical condition that would preclude the use of methylphenidate. A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease
ALT, AST, GGPT or serum creatinine greater then 2X the ULN at Screening
A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
Subjects who have participated in an investigational trial within the past 4 weeks (28 days) are excluded
Subjects who are currently taking antidepressants or other psychotropic medication
Subjects who have initiated psychotherapy during the three months prior to randomization
Subjects with a positive urine drug screen
Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate
