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

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00880217

Purpose

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
Attention Deficit Hyperactivity Disorder Attention Deficit Disorders With Hyperactivity	Drug: Atomoxetine 80 mg/d Drug: Placebo Drug: OROS methylphenidate HCl 54 mg/d Drug: JNJ-31001074 3 mg/d Drug: JNJ-31001074 1 mg/d Drug: JNJ-31001074 10 mg/d	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine hydrochloride Atomoxetine Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Change from baseline in the ADHD rating scale total score [ Time Frame: Through Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary endpoints will include Clinical Global Impression of Change (CGI-C). [ Time Frame: At the end of the double-blind treatment phase (Day 42) ] [ Designated as safety issue: No ]
Other secondary endpoints will include the change from baseline in the Conners Adult ADHD Rating Scale (CAARS-S:SV) and the Clinical Global Impression - Severity (CGI-S). [ Time Frame: Through the end of the double-blind treatment phase (Day 42) ] [ Designated as safety issue: No ]

Enrollment:	430
Study Start Date:	May 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days	Drug: JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days
Experimental: 002 JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days	Drug: JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days
Experimental: 003 JNJ-31001074 10 mg/d 6-mg capsule once daily for 42 days	Drug: JNJ-31001074 10 mg/d 6-mg capsule once daily for 42 days
Active Comparator: 004 Atomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days	Drug: Atomoxetine 80 mg/d 40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
Active Comparator: 005 OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days	Drug: OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
Placebo Comparator: 006 Placebo Placebo capsule once daily for 42 days	Drug: Placebo Placebo capsule once daily for 42 days

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-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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880217

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

No publications provided

Responsible Party:	Clinical Leader Psychiatry, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00880217 History of Changes
Other Study ID Numbers:	CR015964, 31001074ATT2001
Study First Received:	April 9, 2009
Last Updated:	August 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Attention Deficit Hyperactivity Disorder
Adult ADHD
JNJ-31001074

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Atomoxetine
Dopamine Uptake Inhibitors

Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on February 09, 2012