A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study of 3 Dosages of JNJ-31001074 in the Treatment of Adult Subjects With Attention-Deficit/Hyperactivity Disorder

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).

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: JNJ-31001074 1 mg/d; Drug: JNJ-31001074 3 mg/d; Drug: JNJ-31001074 10 mg/d; Drug: Atomoxetine 80 mg/d; Drug: OROS methylphenidate HCl 54 mg/d; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States
  • California
    • Lafayette, California, United States
    • Los Alamitos, California, United States
    • Santa Ana, California, United States
    • Wildomar, California, United States
  • Florida
    • Bradenton, Florida, United States
    • Jacksonville, Florida, United States
    • N. Miami, Florida, United States
    • Orlando, Florida, United States
    • South Miami, Florida, United States
    • St Petersburg, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Idaho
    • Boise, Idaho, United States
    • Eagle, Idaho, United States
  • Illinois
    • Libertyville, Illinois, United States
  • Kansas
    • Overland Park, Kansas, United States
    • Prairie Village, Kansas, United States
  • Michigan
    • Rochester Hills, Michigan, United States
  • Missouri
    • Saint Charles, Missouri, United States
  • New York
    • Mount Kisco, New York, United States
    • New York, New York, United States
  • North Carolina
    • Raleigh, North Carolina, United States
  • Ohio
    • Dayton, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Eugene, Oregon, United States
    • Portland, Oregon, United States
  • Pennsylvania
    • Media, Pennsylvania, United States
  • South Carolina
    • Charleston, South Carolina, United States
  • Tennessee
    • Memphis, Tennessee, United States
  • Texas
    • Austin, Texas, United States
    • Wharton, Texas, United States
  • Vermont
    • Burlington, Vermont, United States
  • Virginia
    • Herndon, Virginia, United States
  • Washington
    • Seattle, Washington, United States
  • Wisconsin
    • Middleton, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with ADHD, confirmed with the Conners Adult ADHD Diagnostic Interview for Diagnostic and Statistical Manual, 4th edition (DSM-IV) (CAADID)
• Patients who meet the cutoff scores for the Conners Adult ADHD Rating Scale (CAARS-S:SV)
• Patients with a Clinical Global Impression - Severity (CGI-S) score of >=4 out of 7
• Patients must have a body mass index between 18.0 and 35.0 (inclusive)
• Women must be postmenopausal for >=2 years, surgically sterile, abstinent, or practice a double-barrier method of birth control in addition to any other forms of birth control
• Women of childbearing potential must have a negative pregnancy test at screening
• Men must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after the last dose of study drug
• Female partners of male patients must be postmenopausal, surgically sterile, abstinent, or also use an effective method of birth control.

Exclusion Criteria:

• Patients with any current Axis I psychiatric disorder
• Patients with a diagnosis of autism or Asperger's syndrome
• Patients with motor tics or a family history or diagnosis of Tourette's syndrome
• Patients with a diagnosis of a primary sleep disorder
• Patients who are suicidal or have previously attempted suicide
• Patients with a history of substance abuse or dependence within 6 months prior to screening
• Patients who have taken any mood stabilizer, antipsychotic, antidepressant, or anxiolytic within 3 months prior to screening
• Patients who have started behavioral or cognitive behavioral therapy specifically for ADHD within 3 months prior to screening
• Patients who have not responded previously to treatment with a psychostimulant medication or to treatment with atomoxetine HCl or OROS methylphenidate HCl.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days	Drug: JNJ-31001074 1 mg/d; 1-mg capsule once daily for 42 days
Experimental: 002; JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days	Drug: JNJ-31001074 3 mg/d; 3-mg capsule once daily for 42 days
Experimental: 003; JNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days	Drug: JNJ-31001074 10 mg/d; 10-mg capsule once daily for 42 days
Active Comparator: 004; Atomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days	Drug: Atomoxetine 80 mg/d; 40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
Active Comparator: 005; OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days	Drug: OROS methylphenidate HCl 54 mg/d; 36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
Placebo Comparator: 006; Placebo capsule once daily for 42 days	Drug: Placebo; Placebo capsule once daily for 42 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the ADHD rating scale total score	Through Day 42

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary endpoints will include Clinical Global Impression of Change (CGI-C).	At the end of the double-blind treatment phase (Day 42)
Other secondary endpoints will include the change from baseline in the Conners Adult ADHD Rating Scale (CAARS-S:SV) and the Clinical Global Impression - Severity (CGI-S).	Through the end of the double-blind treatment phase (Day 42)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Investigators: Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General Publications

• Weisler RH, Pandina GJ, Daly EJ, Cooper K, Gassmann-Mayer C; 31001074-ATT2001 Study Investigators. Randomized clinical study of a histamine H3 receptor antagonist for the treatment of adults with attention-deficit hyperactivity disorder. CNS Drugs. 2012 May 1;26(5):421-34. doi: 10.2165/11631990-000000000-00000.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: April 9, 2009
• First Submitted That Met QC Criteria: April 9, 2009
• First Posted (Estimate): April 13, 2009

Study Record Updates

• Last Update Posted (Estimate): March 4, 2013
• Last Update Submitted That Met QC Criteria: February 27, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders with Hyperactivity; Adult ADHD; JNJ-31001074
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Adrenergic Uptake Inhibitors; Methylphenidate; Atomoxetine Hydrochloride
• Other Study ID Numbers: CR015964; 31001074ATT2001 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)