Status:
COMPLETED
A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 de...
Detailed Description
Stimulant therapy is the mainstay of pharmacologic treatment for attention deficit/hyperactivity disorder (ADHD) in children and adolescents. Methylphenidate is the most commonly prescribed and most f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00246220
Start Date
March 1 2005
End Date
November 1 2006
Last Update
May 17 2011
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