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

NCT ID: NCT00937040

Last Updated: 2013-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-02-28

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

001

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

Group Type: EXPERIMENTAL

OROS MPH

Intervention Type: DRUG

Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks

OROS MPH Tablets

Intervention Type: DRUG

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

002

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Placebo Tablets

Intervention Type: DRUG

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

Interventions

OROS MPH

Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

OROS MPH Tablets

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

Intervention Type: DRUG

Placebo Tablets

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Ortho-McNeil Janssen Scientific Affairs, LLC

References

Goodman DW, Starr HL, Ma YW, Rostain AL, Ascher S, Armstrong RB. Randomized, 6-Week, Placebo-Controlled Study of Treatment for Adult Attention-Deficit/Hyperactivity Disorder: Individualized Dosing of Osmotic-Release Oral System (OROS) Methylphenidate With a Goal of Symptom Remission. J Clin Psychiatry. 2017 Jan;78(1):105-114. doi: 10.4088/JCP.15m10348.

Reference Type: DERIVED

PMID: 27487193 (View on PubMed)

Other Identifiers

CONCERTA-ATT-3014

Identifier Type: OTHER

Identifier Source: secondary_id

CR015058

Identifier Type: -

Identifier Source: org_study_id