A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV

• Described chronic course of ADHD symptomatology from childhood to adulthood, with some symptoms present before age 7 years and continue to meet DSM-IV criteria at the time of assessment

• CAARS score of at least or equal to 24 as determined by investigator at screening visit

• Patient agrees to take only the supplied study drug as treatment for ADHD during the study

• Patient agrees not to initiate a new behavioral modification program during the study or if currently using a behavioral modification program agrees not to change this program during the study.

Exclusion Criteria:

• Known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate

• Has been treated with any methylphenidate-containing medication within 1 month of screening visit

• Participation in and premature withdrawal from 42603ATT3002, CR002479 or 42603ATT3004, CR011068 study

• Known allergy or hypersensitivity to methylphenidate, or components of PR OROS methylphenidate

• Any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder, borderline personality disorder.