A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of three doses of prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult patients with attention deficit/hyperactivity disorder (ADHD).

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

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Central Nervous System Stimulants; Methylphenidate

Criteria

Inclusion Criteria:

• Adults with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) according to DSM-IV criteria

• 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.)

Exclusion Criteria:

• Patients known to be a non-responder to methylphenidate or known to have a child who is a non-responder to methylphenidate

• treated with any methylphenidate-containing medication within 1 month of starting the study

• have any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder, anti-social personality disorder, borderline personality disorder

• family history of schizophrenia or affective psychosis

• patients with motor tics or a history of Tourette's syndrome, or with a substance abuse or dependence disorder, an eating disorder, or mental retardation

• using any medications which may affect the evaluation of study results