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

NCT ID: NCT00246207

Last Updated: 2012-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2005-12-31

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).

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

CONCERTA (OROS methylphenidate hydrochloride)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Ortho Inc., Canada

INDUSTRY

Sponsor Role: lead

Principal Investigators

Janssen-Ortho Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Ortho Inc., Canada

References

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. doi: 10.1185/030079906X154132.

Reference Type: RESULT

PMID: 17166338 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=357&filename=CR003097_CSR.pdf

An open-label study evaluating the safety and effectiveness of OROS\* Methylphenidate (CONCERTA\*) in adults with Attention Deficit Hyperactivity Disorder

Other Identifiers

CR003097

Identifier Type: -

Identifier Source: org_study_id