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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dex-methylphenidate hydrochloride (Focalin XR)

20 mg capsule orally once a day for 7 days

Group Type EXPERIMENTAL

Dex-methylphenidate hydrochloride extended-release (Focalin XR)

Intervention Type DRUG

20 mg capsule orally once a day for 7 days

Placebo

orally once a day for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

orally once a day for 7 days

Interventions

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Dex-methylphenidate hydrochloride extended-release (Focalin XR)

20 mg capsule orally once a day for 7 days

Intervention Type DRUG

Placebo

orally once a day for 7 days

Intervention Type DRUG

Other Intervention Names

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Focalin XR

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No