An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: methylphenidate hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Official(s) and/or principal investigator(s):
McNeil Consumer & Specialty Pharmaceuticals Clinical Trial, Study Director, Affiliation: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

The purpose of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..

Official title: An Evaluation of the Safety and Effectiveness of CONCERTA® (Methylphenidate Hydrochloride), up to 72 mg Daily, in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.

Secondary outcome: Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale score, parent-evaluated weekly during Titration and Double-Blind Phases; Global Assessment of Effectiveness measured weekly during the Titration and Double-Blind Phases; Adverse events

Detailed description: The objective of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride) in the treatment of adolescents with Attention Deficit Hyperactivity Disorder (ADHD). This is a multicenter, randomized, double-blind, placebo-controlled study with adolescents ages 13-18 diagnosed with ADHD. The study consists of four phases. The Screening Phase establishes the diagnosis of ADHD and provides a one-week washout period without any ADHD medication. The Open-Label Titration Phase initiates the treatment of patients with one CONCERTA® 18 mg daily. Thereafter, the dose is increased approximately every 7 days in 18 mg increments (to a maximum of 72 mg daily), until an individualized dose is identified, based on the clinical judgment of the investigator. During the Double-Blind Phase, subjects are randomized to receive either their individualized CONCERTA® dose or a placebo, for a period of 2 weeks. Subjects who successfully complete the Double-Blind Phase are eligible to receive CONCERTA® for an 8-week, Open-Label, Follow-up Phase. The primary efficacy measurement is the total score of the ADHD Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase. Safety assessments include monitoring adverse events, electrocardiograms (ECG), blood pressure, pulse, height and weight throughout the course of the study. The study hypothesis is that CONCERTA® is more effective than placebo in the treatment of Attention Deficit Hyperactivity Disorder in adolescents, and is well tolerated.

Titration Phase: CONCERTA® 18 mg taken orally, once daily, and increased approximately every 7 days in 18 mg increments up to a maximum daily dose of 72 mg. Double-Blind Phase: Individualized dose of CONCERTA® or placebo for 2 weeks. Open-Label Phase: Individualized dose of CONCERTA® for 8 weeks.

Minimum age: 13 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the

Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)

- Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)

Exclusion Criteria:

- Subjects who are known to not respond to methylphenidate

- Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or

its components

- Have marked anxiety, tension or agitation

- Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or

family history of Tourette's disorder

Starting date: March 2002
Ending date: October 2002
Last updated: May 11, 2007