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
2 other identifiers
interventional
430
1 country
35
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2009
CompletedFirst Posted
Study publicly available on registry
April 13, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedMarch 4, 2013
February 1, 2013
8 months
April 9, 2009
February 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the ADHD rating scale total score
Through Day 42
Secondary Outcomes (2)
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)
Study Arms (6)
001
EXPERIMENTALJNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days
002
EXPERIMENTALJNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days
003
EXPERIMENTALJNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days
004
ACTIVE COMPARATORAtomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days
005
ACTIVE COMPARATOROROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days
006
PLACEBO COMPARATORPlacebo capsule once daily for 42 days
Interventions
40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Lafayette, California, United States
Unknown Facility
Los Alamitos, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Wildomar, California, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
North Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
South Miami, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Eagle, Idaho, United States
Unknown Facility
Libertyville, Illinois, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Rochester Hills, Michigan, United States
Unknown Facility
Saint Charles, Missouri, United States
Unknown Facility
Mount Kisco, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Eugene, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Media, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Wharton, Texas, United States
Unknown Facility
Burlington, Vermont, United States
Unknown Facility
Herndon, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Middleton, Wisconsin, United States
Related Publications (1)
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.
PMID: 22519922DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2009
First Posted
April 13, 2009
Study Start
May 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
March 4, 2013
Record last verified: 2013-02