A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT00880217
Last Updated: 2013-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
430 participants
INTERVENTIONAL
2009-05-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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001
JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days
JNJ-31001074 1 mg/d
1-mg capsule once daily for 42 days
002
JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days
JNJ-31001074 3 mg/d
3-mg capsule once daily for 42 days
003
JNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days
JNJ-31001074 10 mg/d
10-mg capsule once daily for 42 days
004
Atomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days
Atomoxetine 80 mg/d
40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
005
OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days
OROS methylphenidate HCl 54 mg/d
36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
006
Placebo capsule once daily for 42 days
Placebo
Placebo capsule once daily for 42 days
Interventions
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Atomoxetine 80 mg/d
40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
Placebo
Placebo capsule once daily for 42 days
OROS methylphenidate HCl 54 mg/d
36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
JNJ-31001074 3 mg/d
3-mg capsule once daily for 42 days
JNJ-31001074 1 mg/d
1-mg capsule once daily for 42 days
JNJ-31001074 10 mg/d
10-mg capsule once daily for 42 days
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Little Rock, Arkansas, United States
Lafayette, California, United States
Los Alamitos, California, United States
Santa Ana, California, United States
Wildomar, California, United States
Bradenton, Florida, United States
Jacksonville, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
South Miami, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Eagle, Idaho, United States
Libertyville, Illinois, United States
Overland Park, Kansas, United States
Prairie Village, Kansas, United States
Rochester Hills, Michigan, United States
Saint Charles, Missouri, United States
Mount Kisco, New York, United States
New York, New York, United States
Raleigh, North Carolina, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Media, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Wharton, Texas, United States
Burlington, Vermont, United States
Herndon, Virginia, United States
Seattle, Washington, United States
Middleton, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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31001074ATT2001
Identifier Type: OTHER
Identifier Source: secondary_id
CR015964
Identifier Type: -
Identifier Source: org_study_id
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