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.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg

Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days.

Group Type EXPERIMENTAL

Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

Intervention Type DRUG

10 mg and/or 20 mg capsules

Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg

Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days.

Group Type ACTIVE_COMPARATOR

Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

Intervention Type DRUG

10 mg and/or 20 mg capsules

Placebo

Two Capsules taken orally once a day for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Comparator

Interventions

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Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

10 mg and/or 20 mg capsules

Intervention Type DRUG

Placebo

Placebo Comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No