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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00880217

Collaborator

(none)

430

Enrollment

Locations

Arms

Duration (Months)

12.3

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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 disorder (ADHD).

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	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 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

430 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 10-mg capsule once daily for 42 days	Drug: JNJ-31001074 10 mg/d 10-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 capsule once daily for 42 days	Drug: Placebo Placebo capsule once daily for 42 days

Outcome Measures

Primary Outcome Measures

Change from baseline in the ADHD rating scale total score [Through Day 42]

Secondary Outcome Measures

Secondary endpoints will include Clinical Global Impression of Change (CGI-C). [At the end of the double-blind treatment phase (Day 42)]
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). [Through the end of the double-blind treatment phase (Day 42)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Little Rock	Arkansas	United States
2	Lafayette	California	United States
3	Los Alamitos	California	United States
4	Santa Ana	California	United States
5	Wildomar	California	United States
6	Bradenton	Florida	United States
7	Jacksonville	Florida	United States
8	N. Miami	Florida	United States
9	Orlando	Florida	United States
10	South Miami	Florida	United States
11	St Petersburg	Florida	United States
12	Atlanta	Georgia	United States
13	Boise	Idaho	United States
14	Eagle	Idaho	United States
15	Libertyville	Illinois	United States
16	Overland Park	Kansas	United States
17	Prairie Village	Kansas	United States
18	Rochester Hills	Michigan	United States
19	Saint Charles	Missouri	United States
20	Mount Kisco	New York	United States
21	New York	New York	United States
22	Raleigh	North Carolina	United States
23	Dayton	Ohio	United States
24	Oklahoma City	Oklahoma	United States
25	Eugene	Oregon	United States
26	Portland	Oregon	United States
27	Media	Pennsylvania	United States
28	Charleston	South Carolina	United States
29	Memphis	Tennessee	United States
30	Austin	Texas	United States
31	Wharton	Texas	United States
32	Burlington	Vermont	United States
33	Herndon	Virginia	United States
34	Seattle	Washington	United States
35	Middleton	Wisconsin	United States

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.