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

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: methylphenidate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen-Ortho Inc., Canada

Official(s) and/or principal investigator(s):
Janssen-Ortho Inc. Clinical Trial, Study Director, Affiliation: Janssen-Ortho Inc., Canada

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).

Official title: An Open-Label Study Evaluating the Safety and Effectiveness of OROS® Methylphenidate Hydrochloride (CONCERTA®) in Adults With Attention Deficit Hyperactivity Disorder

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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: The changes in other effectiveness assessments will be secondary endpoints.

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

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

Starting date: March 2005
Ending date: December 2005
Last updated: May 11, 2007