Clinical trial NCT00880217: A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders with Hyperactivity
Adult ADHD
JNJ-31001074
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2009-04-13
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: Change from baseline in the ADHD rating scale total score
timeFrame: Through Day 42
Secondary outcomes:
measure: Secondary endpoints will include Clinical Global Impression of Change (CGI-C).
timeFrame: At the end of the double-blind treatment phase (Day 42)
measure: 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).
timeFrame: Through the end of the double-blind treatment phase (Day 42)
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Lafayette
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: N. Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Eagle
country: United States
state: Idaho
city: Libertyville
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Prairie Village
country: United States
state: Kansas
city: Rochester Hills
country: United States
state: Michigan
city: Saint Charles
country: United States
state: Missouri
city: Mount Kisco
country: United States
state: New York
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Media
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Wharton
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Herndon
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Middleton
country: United States
state: Wisconsin
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Weisler RH, Pandina GJ, Daly EJ, Cooper K, Gassmann-Mayer C; 31001074-ATT2001 Study Investigators. Randomized clinical study of a histamine H3 receptor antagonist for the treatment of adults with attention-deficit hyperactivity disorder. CNS Drugs. 2012 May 1;26(5):421-34. doi: 10.2165/11631990-000000000-00000.