- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00246207
CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults
February 9, 2012 updated by: Janssen-Ortho Inc., Canada
An Open-label Study Evaluating the Safety and Effectiveness of OROS Methylphenidate Hydrochloride (CONCERTA) in Adults With Attention Deficit Hyperactivity Disorder
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).
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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The changes in other effectiveness assessments will be secondary endpoints.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
October 28, 2005
First Submitted That Met QC Criteria
October 28, 2005
First Posted (Estimate)
October 30, 2005
Study Record Updates
Last Update Posted (Estimate)
February 10, 2012
Last Update Submitted That Met QC Criteria
February 9, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Disease
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- CR003097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Disorder With Hyperactivity
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Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Karolinska InstitutetCompletedAttention Deficit Disorder With Hyperactivity (ADHD)Sweden
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Rabin Medical CenterNG Solutions LtdRecruitingADHD - Attention Deficit Disorder With HyperactivityIsrael
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Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
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Clinical and Translational Genome Research Institute...Children's Specialized HospitalTerminatedAttention Deficit Disorders With HyperactivityUnited States
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University of PennsylvaniaCompletedAttention Deficit Disorder With Hyperactivity (ADHD)United States
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Massachusetts General HospitalRecruitingAttention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
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Nemours Children's ClinicCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
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New River PharmaceuticalsShireCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersUnited States
Clinical Trials on CONCERTA (OROS methylphenidate hydrochloride)
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Massachusetts General HospitalMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.CompletedAttention Deficit Hyperactivity DisorderUnited States
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Bundang CHA HospitalHallym University Medical CenterCompletedAttention Deficit Hyperactivity DisorderKorea, Republic of
-
Massachusetts General HospitalOrtho-McNeil Janssen Scientific Affairs, LLCCompleted
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Massachusetts General HospitalThe American Professional Society of ADHD and Related Disorders (APSARD)CompletedAttention Deficit Hyperactivity Disorder (ADHD) | Executive Function Deficits (EFD)United States
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Boston Children's HospitalNational Institute of Mental Health (NIMH)CompletedEpilepsy | Attention Deficit Disorder With HyperactivityUnited States
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Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH)CompletedADHD - Combined Type | ADHD - Inattentive TypeUnited States
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Children's Hospital of PhiladelphiaOrtho-McNeil Janssen Scientific Affairs, LLCCompletedAttention Deficit Hyperactivity DisorderUnited States
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University of Illinois at ChicagoNational Institute of Mental Health (NIMH)Completed
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ShireCompletedADHDBelgium, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
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Massachusetts General HospitalOrtho-McNeil Janssen Scientific Affairs, LLCCompletedADHD | Attention Deficit Hyperactivity DisorderUnited States