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

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)

Conditions

Attention Deficit Disorder With Hyperactivity

Study Type

Interventional

Study Design

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

Further Details

Primary Outcome Measures:

• 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 Measures:

• 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

Study Start

March 2002; Completion Date: October 2002

Eligibility & Criteria

• Ages Eligible for Study: 13 Years to 18 Years
• Genders Eligible for Study: Both

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

Total Enrolment

200

Contact Details

Click here to see the results of this study.