Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Osmotic Release Oral System (OROS®) Extended Release Methylphenidate HCl CONCERTA® (OROS MPH)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 357
Healthy volunteers: no

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 adults with ADHD when compared to placebo as demonstrated using specific study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled study to evaluate the efficacy and safety of OROS MPH using the optimal dose for each adult patient in the study with ADHD. The primary efficacy variable in this study is the change from baseline to final evaluation using the Adult ADHD Investigator Symptom Rating Scale (AISRS) to measure patient ADHD symptoms. Participants will also be assessed for adverse events throughout the study. Patients will initiate treatment with oral OROS MPH 18 mg or matching placebo at baseline and continue morning dosing with increases every week until an optimal dose is achieved, up to the maximum of 72 mg/day of OROS MPH or matching placebo. Eligible patients will remain in the study for a maximum of 6 weeks.

Arms:
arm 1: OROS MPH Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks arm 2: Placebo Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks

Interventions: intervention 1: OROS MPH intervention 2: Placebo intervention 3: OROS MPH Tablets intervention 4: Placebo Tablets
Intervention descriptions: intervention 1: Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks intervention 2: Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily for 6 weeks intervention 3: Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks intervention 4: Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks

Protocol document: