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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00880217
First received: April 9, 2009
Last updated: February 27, 2013
Last verified: February 2013

April 9, 2009
February 27, 2013
May 2009
January 2010   (final data collection date for primary outcome measure)
Change from baseline in the ADHD rating scale total score [ Time Frame: Through Day 42 ] [ Designated as safety issue: No ]
Change from baseline in the ADHD rating scale total score
Complete list of historical versions of study NCT00880217 on ClinicalTrials.gov Archive Site
  • 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 ]
Secondary endpoints will include Clinical Global Impression of Change (CGI-C).
Not Provided
Not Provided
 
A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Atomoxetine 80 mg/d
    40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
  • Drug: Placebo
    Placebo capsule once daily for 42 days
  • Drug: OROS methylphenidate HCl 54 mg/d
    36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
  • Drug: JNJ-31001074 3 mg/d
    3-mg capsule once daily for 42 days
  • Drug: JNJ-31001074 1 mg/d
    1-mg capsule once daily for 42 days
  • Drug: JNJ-31001074 10 mg/d
    10-mg capsule once daily for 42 days
  • Experimental: 001
    JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days
    Intervention: Drug: JNJ-31001074 1 mg/d
  • Experimental: 002
    JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days
    Intervention: Drug: JNJ-31001074 3 mg/d
  • Experimental: 003
    JNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days
    Intervention: Drug: JNJ-31001074 10 mg/d
  • Active Comparator: 004
    Atomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days
    Intervention: Drug: Atomoxetine 80 mg/d
  • 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
    Intervention: Drug: OROS methylphenidate HCl 54 mg/d
  • Placebo Comparator: 006
    Placebo capsule once daily for 42 days
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00880217
CR015964, 31001074ATT2001
Yes
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP