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A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.

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ClinicalTrials.gov Identifier: NCT00246220
Recruitment Status : Completed
First Posted : October 31, 2005
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Janssen Pharmaceutica N.V., Belgium

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: methylphenidate hydrochloride Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Study Completion Date : November 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246220


Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
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Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
More Information
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Additional Information:
A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study Evaluating Safety & Efficacy of CONCERTA OROS (18, 36 and 72 mg/day) With Open-Label (OL) Extension in Adults with ADHD  This link exits the ClinicalTrials.gov site |A Multicentre, Randomized, DB, PCB controlled, Parallel Group, Dose-Response Study to Evaluate Safety and Efficacy of Prolonged Release OROS®methylphenidate (18, 36 and 72 mg/day), With OL Extension, in Adults with ADH  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00246220     History of Changes
Other Study ID Numbers: CR002479
First Posted: October 31, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: April 2010
Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Attention deficit/hyperactivity disorder
methylphenidate
central nervous system stimulants
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents