Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

Completed · Phase 4 · Has a placebo group

Conditions studied: Attention-Deficit/Hyperactivity Disorder (ADHD)

In brief

This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.

Key facts

Study ID

NCT00776009

Run by

Novartis Pharmaceuticals

People needed

165

Starts

2008-10-01

Expected to finish

2008-12-01

Last updated by the study team

2011-06-08

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 primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, 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.

You may not qualify if…

• Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
• Diagnosed with or history of 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 (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of Normal) 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)
• 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

• Clinical Study Center, LLC — Little Rock, Arkansas, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Center for Psychiatry and Behavioral Medicine, Inc. — Las Vegas, Nevada, United States
• Bayou City Research — Houston, Texas, United States
• Claghorn-Lesem Research Clinic — Houston, Texas, United States
• Behavioral Neurology — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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