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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Atomoxetine Hydrochloride; Methylphenidate

Criteria

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.