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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00880217 |
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).
Condition | Intervention | Phase |
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Attention Deficit Hyperactivity Disorder Attention Deficit Disorders With Hyperactivity |
Drug: Atomoxetine 80 mg/d Drug: JNJ-31001074 3 mg/d Drug: OROS methylphenidate HCl 54 mg/d Drug: JNJ-31001074 10 mg/d Drug: JNJ-31001074 1 mg/d Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study of 3 Dosages of JNJ-31001074 in the Treatment of Adult Subjects With Attention-Deficit/Hyperactivity Disorder |
Estimated Enrollment: | 426 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Experimental |
Drug: JNJ-31001074 1 mg/d
1-mg capsule once daily for 42 days
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002: Experimental |
Drug: JNJ-31001074 3 mg/d
3-mg capsule once daily for 42 days
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003: Experimental |
Drug: JNJ-31001074 10 mg/d
6-mg capsule once daily for 42 days
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004: Active Comparator |
Drug: Atomoxetine 80 mg/d
40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
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005: Active Comparator |
Drug: OROS methylphenidate HCl 54 mg/d
36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
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006: Placebo Comparator |
Drug: Placebo
Placebo capsule once daily for 42 days
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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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Clinical Leader Psychiatry ) |
Study ID Numbers: | CR015964, 31001074ATT2001 |
Study First Received: | April 9, 2009 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00880217 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Attention Deficit Hyperactivity Disorder Adult ADHD JNJ-31001074 |
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Attention Deficit and Disruptive Behavior Disorders Methylphenidate Atomoxetine Central Nervous System Stimulants Dyskinesias |
Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Atomoxetine Methylphenidate Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders |
Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Disease Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias Pharmacologic Actions Neurologic Manifestations Dopamine Agents Central Nervous System Agents |