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View Clinical Trial (Medical Research Study)
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A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) - NCT00880217- (Clinical Trial 283976)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy283976.aspx
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| City: |
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Middleton |
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State:
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WI |
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| Conditions: |
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Attention Deficit Hyperactivity Disorder - Attention Deficit Disorders With Hyperactivity |
| Purpose: |
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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).
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| Study summary: |
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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-group, multicenter study in patients with adult ADHD. The study
population will include approximately 426 male and female patients, 18 to 55 years of age
(inclusive) with a DSM-IV diagnosis of ADHD, who will be randomly assigned (like flipping a
coin) in a 1:1:1:1:1:1 ratio to 1 of 6 treatment groups (1 milligrams per day [mg/d]
JNJ-31001074, 3 mg/d JNJ-31001074, 10 mg/d JNJ 31001074, 80 mg/d atomoxetine HCl, 54 mg/d
controlled-release [OROS] methylphenidate HCl, or placebo). Study centers will make every
attempt to include approximately 4 women for every 10 men randomized. The study will consist
of 3 phases: a screening phase of up to 7 days; a 42-day double-blind treatment phase; and a
7-day post-treatment phase, in which the investigator staff will call patients 7 days after
the last dose of study drug, to ask about any adverse events. The total duration of patient
participation will be approximately 8 weeks. During the screening and double-blind treatment
phases, patients will have periodic assessments at visits (screening, Day 1, Day 4, Day 7,
Day 14, Day 28, and Day 42) of the following: severity of ADHD symptoms, including
inattention and impulsivity; daily function; sleep experience; and cigarette consumption and
cigarette craving. In addition, patients will be asked to include an adult household member
to complete the observer version of the Conners Adult ADHD Rating Scale (CAARS-O:SV) at the
beginning and end of the study. Patients will take one oral capsules each day in the morning
upon awakening, either JNJ-31001074 (1, 3, or 10 mg), matching atomoxetine HCL (40 or 80
mg), matching OROS methylphenidate HCl (36 or 54 mg), or matching placebo. For atomoxetine
HCl, patients will receive 40 mg/d for the first 3 days, and 80 mg/d for the remainder of
the study. For OROS methylphenidate HCl, patients will receive 36 mg/d for the first 3 days,
and 54 mg/d for the remainder of the study. |
| Criteria: |
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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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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