Clinical trial NCT00937040: Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: A Placebo Controlled Double-Blind, Parallel Group, Individualizing Dosing Study Optimizing Treatment of Adults With Attention Deficit Hyperactivity Disorder to an Effective Response With OROS Methylphenidate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Osmotic Release Oral System (OROS®) Extended Release Methylphenidate HCl
CONCERTA® (OROS MPH)
Lead sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2009-07-10
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis
timeFrame: Baseline, endpoint (42 days or early discontinuation)
Secondary outcomes:
measure: Reaction Time Domain of the Stroop Test (Cognitive and Executive Function)
timeFrame: Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)
measure: Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function)
timeFrame: Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)
measure: Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Subject's Rating of Endicott Work Productivity Scale (EWPS)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Subject's Rating of Dyadic Satisfaction Subscale (DSS)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD?
timeFrame: Endpoint (42 days or early discontinuation)
measure: Responder Rate Using AISRS
timeFrame: Endpoint (42 days or early discontinuation)
measure: Clinical Global Impression - Severity of Illness Subscale (CGI-S)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Significant Other's (a Spouse, Significant Other or Other Adult in the Household, Described in This Study as the Designated Observer) Rating of Adult ADHD Rating Scale IV
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Designated Observer's (DO) Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication for ADHD Your Partner is Taking?
timeFrame: Endpoint (42 days or early discontinuation)
measure: Adult ADHD Self-Report Scale (ASRS) Over Time
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Pittsburgh Sleep Quality Index (PSQI) Total Score
timeFrame: Baseline, endpoint (42 days or early discontinuation)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, endpoint (42 days or early discontinuation)
Other outcomes:
Locations:
Study officials:
affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
name: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.