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

Completed · Phase 2 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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).

Key facts

Study ID

NCT00880217

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

430

Starts

2009-05-01

Expected to finish

2010-01-01

Last updated by the study team

2013-03-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Lafayette, California, United States
• Study site — Los Alamitos, California, United States
• Study site — Santa Ana, California, United States
• Study site — Wildomar, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Eagle, Idaho, United States
• Study site — Libertyville, Illinois, United States
• Study site — Overland Park, Kansas, United States
• Study site — Prairie Village, Kansas, United States
• Study site — Rochester Hills, Michigan, United States
• Study site — Saint Charles, Missouri, United States
• Study site — Mount Kisco, New York, United States
• Study site — New York, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Dayton, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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