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

Sponsor:	Janssen Pharmaceutica N.V., Belgium
Information provided by:	Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:	NCT00246220

Purpose

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	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: methylphenidate hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:

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:

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

Enrollment:	402
Study Start Date:	March 2005
Study Completion Date:	November 2006

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246220

Sponsors and Collaborators

Janssen Pharmaceutica N.V., Belgium

Investigators

Study Director:

Janssen Pharmaceutica N.V. Clinical Trial

Janssen Pharmaceutica N.V.

More Information

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

This link exits the ClinicalTrials.gov site

Publications:

Medori R, Ramos-Quiroga JA, Casas M, Kooij JJ, Niemelä A, Trott GE, Lee E, Buitelaar JK. A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2008 May 15;63(10):981-9. Epub 2008 Jan 22.

Study ID Numbers:	CR002479
Study First Received:	October 28, 2005
Last Updated:	September 28, 2009
ClinicalTrials.gov Identifier:	NCT00246220 History of Changes
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:

Attention deficit/hyperactivity disorder
methylphenidate
central nervous system stimulants

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010