A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)

Completed · Phase 4 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.

Key facts

Study ID

NCT00564954

Run by

Novartis Pharmaceuticals

People needed

86

Starts

2007-10-01

Expected to finish

2007-11-01

Last updated by the study team

2012-04-27

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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
• Other protocol defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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