A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

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).
    

Detailed 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.
    

Intervention name(s): Atomoxetine 80 mg/d; Placebo; OROS methylphenidate HCl 54 mg/d; JNJ-31001074 3 mg/d; JNJ-31001074 1 mg/d; JNJ-31001074 10 mg/d
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days; Placebo capsule once daily for 42 days; 36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days; 3-mg capsule once daily for 42 days; 1-mg capsule once daily for 42 days; 10-mg capsule once daily for 42 days
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders with Hyperactivity; Adult ADHD; JNJ-31001074