Overview

Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ortho-McNeil Janssen Scientific Affairs, LLC
Treatments:
Methylphenidate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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