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

February 27, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Lafayette, California, United States
      • Los Alamitos, California, United States
      • Santa Ana, California, United States
      • Wildomar, California, United States
    • Florida
      • Bradenton, Florida, United States
      • Jacksonville, Florida, United States
      • N. Miami, Florida, United States
      • Orlando, Florida, United States
      • South Miami, Florida, United States
      • St Petersburg, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
      • Eagle, Idaho, United States
    • Illinois
      • Libertyville, Illinois, United States
    • Kansas
      • Overland Park, Kansas, United States
      • Prairie Village, Kansas, United States
    • Michigan
      • Rochester Hills, Michigan, United States
    • Missouri
      • Saint Charles, Missouri, United States
    • New York
      • Mount Kisco, New York, United States
      • New York, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Dayton, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Media, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Wharton, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Herndon, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Middleton, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in the ADHD rating scale total score
Time Frame: Through Day 42
Through Day 42

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Secondary endpoints will include Clinical Global Impression of Change (CGI-C).
Time Frame: At the end of the double-blind treatment phase (Day 42)
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).
Time Frame: Through the end of the double-blind treatment phase (Day 42)
Through the end of the double-blind treatment phase (Day 42)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR015964
  • 31001074ATT2001 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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