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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: OROS MPH Tablets; Drug: Placebo; Drug: OROS MPH; Drug: Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00937040

CR015058

CONCERTA-ATT-3014 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 357 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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357 participants in 2 patient groups, including a placebo group

001

Experimental group

Description:

OROS MPH Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks

Treatment:

Drug: OROS MPH

Drug: OROS MPH Tablets

002

Placebo Comparator group

Description:

Placebo Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks

Treatment:

Drug: Placebo

Drug: Placebo Tablets