Status:
COMPLETED
A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 disord...
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-gr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00880217
Start Date
May 1 2009
End Date
January 1 2010
Last Update
March 4 2013
Active Locations (35)
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1
Little Rock, Arkansas, United States
2
Lafayette, California, United States
3
Los Alamitos, California, United States
4
Santa Ana, California, United States