Status:
COMPLETED
Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects w...
Detailed Description
This is an open label, multicentre extension study to trial 42603ATT3002. Patients, who were enrolled to trial 42603ATT3002 must have had a diagnosis of ADHD with some symptoms already present at the ...
Eligibility Criteria
Inclusion
- Patient has completed study CR002479 (42603ATT3002), according to protocol
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)1 and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV (CAADID)
- Healthy on the basis of physical examination, medical history
- Patient is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments
- Amendment (double-blind placebo-controlled period): written informed consent
- patient must have completed at least 52 weeks of open-label treatment and must have been on a stable daily dose of (PR) OROS methlyphenidate prior to inclusion to this phase
Exclusion
- Patient is known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate
- Allergy or hypersensitivty to methlyphenidate
- 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
- Use of other anti-depressants (unless patient has been on a stable dosage during the 42603ATT3002 trial, in which case treatment may continue as long as dosage remains unchanged for the duration of the study) or mood stabilisers (e.g. anti-epileptics, lithium)
- Any medication likely to interfere with safe administration of methylphenidate, or any conditions that are contraindicated for use of methlyphenidate
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00307684
Start Date
January 1 2006
End Date
July 1 2008
Last Update
April 21 2014
Active Locations (21)
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1
Paris, France
2
Ahrensburg, Germany
3
Aschaffenburg, Germany
4
Berlin, Germany