A Study of the Effectiveness and Safety of Prolonged-Release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.
Information source: Janssen Pharmaceutica N.V., Belgium
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: methylphenidate hydrochloride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen Pharmaceutica N.V., Belgium Official(s) and/or principal investigator(s):
Janssen Pharmaceutica N.V. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica N.V., Belgium
Summary
The purpose of this study is to evaluate the effectiveness and safety of three doses of
prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult
patients with attention deficit/hyperactivity disorder (ADHD).
Clinical Details
Official title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study To Evaluate the Safety And Efficacy Of Prolonged Release OROS® Methylphenidate Hydrochloride (18, 36 and 72 mg/Day), With Open-Label Extension, In Adults With Attention Deficit/Hyperactivity Disorder
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.
Secondary outcome: Changes from baseline to the end of treatment in: Conners' Adult ADHD Rating Scale; Clinical Global Impression; Sheehan's Disability Scale; Quality of Life Enjoyment and Satisfaction Questionnaire; and Global Assessment of Effectiveness
Detailed description:
Stimulant therapy is the mainstay of pharmacologic treatment for attention
deficit/hyperactivity disorder (ADHD) in children and adolescents. Methylphenidate is the
most commonly prescribed and most frequently studied stimulant medication for children and
adolescents with this disorder. It is widely acknowledged in the scientific literature that
ADHD often will persist into adulthood. Few large-scale, rigorous studies have been conducted
to investigate the effectiveness and safety of stimulant therapy in treating ADHD in adults.
This is a multicentre, double-blind, randomised, placebo-controlled, parallel group,
dose-response study comparing three doses of prolonged-release methylphenidate (18, 36, and
72 mg once-daily) versus placebo in adult patients with ADHD. The primary efficacy outcome
will be the change from baseline to the end of the double-blind phase in the sum of the
inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners'
Adult ADHD Rating Scale (CAARS). Additional measures of effectiveness will include the
following scales: CAARS-self report, to rate items pertaining to the patient's
behavior/problems; Clinical Global Impression (CGI), to rate the severity of a patient's
illness; Sheehan's Disability Scale (SDS), to measure the extent to which a patient's work,
social life or leisure activities and home life or family responsibilities are impaired by
his/her symptoms; Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q); and the
Global Assessment of Effectiveness. Safety and tolerability will be monitored throughout the
study. The study hypothesis is that prolonged-release methylphenidate taken once-daily will
produce clinically significant improvements compared with placebo on measures of inattention
and hyperactivity/impulsivity of the Conners' Adult ADHD Rating Scale in patients with adult
ADHD.
Prolonged-release methylphenidate 18, 36 or 72 mg oral capsules, or placebo, taken once-daily
for 5 weeks. Eligible patients may continue prolonged-release methylphenidate in an
open-label extension study for an additional 7 weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Adults with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) according to
DSM-IV criteria
ADHD symptoms from childhood to adulthood, with some symptoms present before age 7 years
which continue to meet DSM-IV criteria at the time of assessment. (ADHD is not diagnosed if
the symptoms are better accounted for by another psychiatric disorder.)
Exclusion Criteria:
Patients known to be a non-responder to methylphenidate or known to have a child who is a
non-responder to methylphenidate
Treated with any methylphenidate-containing medication within 1 month of starting the
study
Have any clinically unstable psychiatric condition including, but not limited to the
following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder,
anti-social personality disorder, borderline personality disorder
Family history of schizophrenia or affective psychosis
Patients with motor tics or a history of Tourette's syndrome, or with a substance abuse or
dependence disorder, an eating disorder, or mental retardation
Using any medications which may affect the evaluation of study results
Locations and Contacts
Additional Information
Starting date: March 2005
Ending date: November 2006
Last updated: October 19, 2007
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