Status:
COMPLETED
Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated with OROS MPH to those treated with placebo.
Detailed Description
The hypothesis is that Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCL (OROS MPH) is safe and effective in improving Attention Deficit Hyperactivity Disorder (ADHD) symptoms in...
Eligibility Criteria
Inclusion
- Adults
- ADHD diagnosis (any type: Combined, Predominantly Inattentive, or Predominantly Hyperactive-Impulsive)
- Patients with an Adult ADHD Investigator Symptom Rating Scale (AISRS) score greater than 24 at screening/baseline
- Ability to read and understand English
Exclusion
- Any significant history of cardiovascular disease or cardiovascular disease detectable via ECG
- History of diagnosis of substance or alcohol dependence or admission/hospitalization for rehabilitation for dependence
- Current neurologic or psychiatric diagnosis that would make patient inappropriate for participation
- Anxiety assessments of moderate or severe
- Depression assessments of moderate or severe
- History or current suicidal thoughts or attempts
- Known allergies, hypersensitivity, or intolerance to OROS MPH
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00937040
Start Date
July 1 2009
End Date
February 1 2010
Last Update
July 30 2013
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