A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Summary
The purpose of this study is to evaluate the efficacy and safety/tolerability of 3 different dosages of JNJ-31001074 compared with placebo in adult patients with attention-deficit/hyperactivity disorder (ADHD).
Description
This will be a randomized (study drug assigned by chance), double-blind (neither the investigator nor the patient know the name of the assigned study drug), placebo- and active-controlled, parallel-group, multicenter study in patients with adult ADHD. The study population will include approximately 426 male and female patients, 18 to 55 years of age (inclusive) with a DSM-IV diagnosis of ADHD, who will be randomly assigned (like flipping a coin) in a 1:1:1:1:1:1 ratio to 1 of 6 treatment groups (1 milligrams per day [mg/d] JNJ-31001074, 3 mg/d JNJ-31001074, 10 mg/d JNJ 31001074, 80 mg/d atomoxetine HCl, 54 mg/d controlled-release [OROS] methylphenidate HCl, or placebo). Study centers will make every attempt to include approximately 4 women for every 10 men randomized. The study will consist of 3 phases: a screening phase of up to 7 days; a 42-day double-blind treatment phase; and a 7-day post-treatment phase, in which the investigator staff will call patients 7 days after the last dose of study drug, to ask about any adverse events. The total duration of patient participation will be approximately 8 weeks. During the screening and double-blind treatment phases, patients will have periodic assessments at visits (screening, Day 1, Day 4, Day 7, Day 14, Day 28, and Day 42) of the following: severity of ADHD symptoms, including inattention and impulsivity; daily function; sleep experience; and cigarette consumption and cigarette craving. In addition, patients will be asked to include an adult household member to complete the observer version of the Conners Adult ADHD Rating Scale (CAARS-O:SV) at the beginning and end of the study. Patients will take one oral capsules each day in the morning upon awakening, either JNJ-31001074 (1, 3, or 10 mg), matching atomoxetine HCL (40 or 80 mg), matching OROS methylphenidate HCl (36 or 54 mg), or matching placebo. For atomoxetine HCl, patients will receive 40 mg/d for the first 3 days, and 80 mg/d for the remainder of the study. For OROS methylphenidate HCl, patients will receive 36 mg/d for the first 3 days, and 54 mg/d for the remainder of the study.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Attention Deficit Hyperactivity Disorder
Intervention
Atomoxetine 80 mg/d, Placebo, JNJ-31001074 1 mg/d, JNJ-31001074 3 mg/d, JNJ-31001074 10 mg/d, OROS methylphenidate HCl 54 mg/d
Status
Completed
Source
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00880217
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Methylphenidate
A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Introversion (psychology)
A state in which attention is largely directed inward upon one's self.
Clinical Trials
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PubMed Articles
Predictors of treatment outcome in adults with ADHD treated with OROS(®) methylphenidate.
We conducted a post-hoc analysis of the Long-Acting MethylpheniDate in Adult attention-deficit hyperactivity disorder (LAMDA) study to investigate predictors of response in adults with ADHD randomly a...
Aim This study investigated whether components of attention and executive functioning improve when children with attention-deficit-hyperactivity disorder (ADHD) are treated with osmotic-release ora...
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The aim of this study was to compare the safety, efficacy, tolerability, and the effects of atomoxetine and OROS-MPH on executive functions in children with ADHD. This study was an open-label study th...
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