Status:
COMPLETED
CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this pilot study is to evaluate the safety, tolerability and potential effectiveness of CONCERTA® (methylphenidate hydrochloride extended-release tablets), a central nervous system (CN...
Detailed Description
CONCERTA® is a long-acting form of methylphenidate (a CNS stimulant). Methylphenidate is a recognized first-line treatment for ADHD in children and adolescents. It is widely acknowledged in the scient...
Eligibility Criteria
Inclusion
- Have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Diseases (DSM-IV) obtained via clinical interview and confirmed by the Wender Utah Rating Scale
- 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.)
- investigator-rated CAARS (Conners' Adult ADHD Rating Scale) baseline score greater than or equal to 24
- Clinical Global Impression of Severity baseline score greater than or equal to 4 and a total Montgomery Asberg Depression Rating score at baseline of less than or equal to 16.
Exclusion
- Have been treated with any methylphenidate- or amphetamine-containing medication within 4 weeks of screening visit
- any clinically unstable psychiatric condition including the following, but not limited to: acute mood disorder, schizophrenia, bipolar disorder, acute obsessive compulsive disorder, anti-social personality disorder
- subjects with marked anxiety, tension, aggression or agitation, Autism or Asperger's syndrome
- a diagnosis of substance abuse or dependence within 6 months prior to screening evaluation
- use of other psychotropic medications used to treat non-ADHD psychiatric disorders, if the dose of the medication has not remained stable for a minimum of 4 weeks prior to trial entry.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00246207
Start Date
March 1 2005
End Date
December 1 2005
Last Update
February 10 2012
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