CONCERTA® (OROS® Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults - Full Text View

Sponsored by:	Janssen-Ortho Inc., Canada
Information provided by:	Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:	NCT00246207

Purpose

The purpose of this pilot study is to evaluate the safety, tolerability and potential effectiveness of CONCERTA® (methylphenidate hydrochloride extended-release tablets), a central nervous system (CNS) stimulant for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD).

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study Evaluating the Safety and Effectiveness of OROS® Methylphenidate Hydrochloride (CONCERTA®) 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-Ortho Inc., Canada:

Primary Outcome Measures:

The primary effectiveness outcomes will be the changes in the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated CAARS (Conners' Adult ADHD Rating Scale) from baseline to the end of treatment.

Secondary Outcome Measures:

The changes in other effectiveness assessments will be secondary endpoints.

Estimated Enrollment:	30
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2005

Detailed Description:

CONCERTA® is a long-acting form of methylphenidate (a CNS stimulant). Methylphenidate is a recognized first-line treatment for ADHD in children and adolescents. It is widely acknowledged in the scientific literature that the disorder often will persist in adulthood, and is associated with significant morbidity and undesirable outcomes.

Despite this, few studies have been conducted to investigate the efficacy and safety of stimulant therapy in treating ADHD in adults. As a consequence, drug treatment options for adult sufferers of ADHD are limited. The primary objective of this pilot, open-label study is to evaluate the safety, tolerability and potential effectiveness of CONCERTA® (18, 36, 54 or 72 mg of methylphenidate hydrochloride, administered once-daily) in adult subjects with Attention Deficit Hyperactivity Disorder (ADHD). Patients cannot have been treated with any methylphenidate- or amphetamine-containing medication within 4 weeks of screening visit. Once deemed eligible, subjects will be started on 18 mg of CONCERTA® once-daily for 3 days, titrated up on Day 4 to 36 mg and maintained at this dose for 7 days. Depending on patient response, the dose of CONCERTA® can continue to be titrated up every 7 days, first to 54 mg and then to a maximum of 72 mg per day, in order to achieve the optimal dose for each patient. The primary efficacy outcomes will be the changes from baseline to the end of treatment in the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale (CARRS). Safety and tolerability will be monitored throughout the study. The study hypothesis is that stimulant therapy in treating adult ADHD will be safe and effective, measured by the Conners' Adult ADHD Rating Scale (CAARS) score.

CONCERTA® is taken orally, once-daily. Starting with CONCERTA® 18 mg for 3 days, subjects are titrated up on Day 4 to 36 mg for 7 days. Depending on response, tolerability and clinician's discretion, the dose of CONCERTA® can continue to be titrated up every 7 days, first to 54 mg and then to a maximum of 72 mg per day (two 36 mg tablets), until each subject's optimal dose is achieved. The titration period will last a maximum of 24 days.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Diseases (DSM-IV) obtained via clinical interview and confirmed by the Wender Utah Rating Scale
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.)
Investigator-rated CAARS (Conners' Adult ADHD Rating Scale) baseline score greater than or equal to 24
Clinical Global Impression of Severity baseline score greater than or equal to 4 and a total Montgomery Asberg Depression Rating score at baseline of less than or equal to 16

Exclusion Criteria:

Have been treated with any methylphenidate- or amphetamine-containing medication within 4 weeks of screening visit
Any clinically unstable psychiatric condition including the following, but not limited to: acute mood disorder, schizophrenia, bipolar disorder, acute obsessive compulsive disorder, anti-social personality disorder
Subjects with marked anxiety, tension, aggression or agitation, Autism or Asperger's syndrome
A diagnosis of substance abuse or dependence within 6 months prior to screening evaluation
Use of other psychotropic medications used to treat non-ADHD psychiatric disorders, if the dose of the medication has not remained stable for a minimum of 4 weeks prior to trial entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246207

Sponsors and Collaborators

Janssen-Ortho Inc., Canada

Investigators

Study Director:

Janssen-Ortho Inc. Clinical Trial

Janssen-Ortho Inc., Canada

More Information

Additional Information:

An open-label study evaluating the safety and effectiveness of OROS* Methylphenidate (CONCERTA*) in adults with Attention Deficit Hyperactivity Disorder This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Fallu A, Richard C, Prinzo R, Binder C. Does OROS-methylphenidate improve core symptoms and deficits in executive function? Results of an open-label trial in adults with attention deficit hyperactivity disorder. Curr Med Res Opin. 2006 Dec;22(12):2557-66.

Study ID Numbers:	CR003097
Study First Received:	October 28, 2005
Last Updated:	May 11, 2007
ClinicalTrials.gov Identifier:	NCT00246207 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Janssen-Ortho Inc., Canada:

once-day oral tablets
Attention Deficit Hyperactivity Disorder

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Signs and Symptoms

Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents

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 September 10, 2009