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CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults

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ClinicalTrials.gov Identifier: NCT00246207
Recruitment Status : Completed
First Posted : October 30, 2005
Last Update Posted : February 10, 2012
Sponsor:
Information provided by:
Janssen-Ortho Inc., Canada

Brief Summary:
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 or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: CONCERTA (OROS methylphenidate hydrochloride) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study Evaluating the Safety and Effectiveness of OROS Methylphenidate Hydrochloride (CONCERTA) in Adults With Attention Deficit Hyperactivity Disorder
Study Start Date : March 2005
Actual Study Completion Date : December 2005





Primary Outcome Measures :
  1. 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 :
  1. The changes in other effectiveness assessments will be secondary endpoints.


Information from the National Library of Medicine

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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:

  • 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.

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): NCT00246207


Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Investigators
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Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada

Additional Information:
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00246207    
Other Study ID Numbers: CR003097
First Posted: October 30, 2005    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Keywords provided by Janssen-Ortho Inc., Canada:
Attention Deficit Hyperactivity Disorder
once-day oral tablets
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