Status:
COMPLETED
A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Attention Deficit/ Hyperactivity Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 defici...
Detailed Description
The primary objective 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 attent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT00714688
Start Date
February 1 2008
End Date
April 1 2009
Last Update
May 8 2014
Active Locations (42)
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1
Antwerp, Belgium
2
Brussels, Belgium
3
Kortenberg, Belgium
4
Mechelen, Belgium