Attention Deficit Hyperactivity DisorderPhase 2NCT00880217
A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing Atomoxetine 80 mg/d, OROS methylphenidate HCl 54 mg/d and JNJ-31001074 3 mg/d in people with Attention Deficit Hyperactivity Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 35 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine 80 mg/d, OROS methylphenidate HCl 54 mg/d and JNJ-31001074 3 mg/d
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 35 sitesUnited States
- Study dates
- May 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Boise, Idaho
Study site
Bradenton, Florida
Study site
Burlington, Vermont
Study site
Charleston, South Carolina
Study site
Dayton, Ohio
Study site
Eagle, Idaho
Study site
Eugene, Oregon
Study site
Herndon, Virginia
Study site
Jacksonville, Florida
Study site
Lafayette, California
Study site
Libertyville, Illinois
Study site
Little Rock, Arkansas
Study site
Los Alamitos, California
Study site
Media, Pennsylvania
Study site
Memphis, Tennessee
Study site
Middleton, Wisconsin
Study site
Mount Kisco, New York
Study site
New York, New York
Study site
North Miami, Florida
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida
Study site
Overland Park, Kansas
Study site
Portland, Oregon
Study site
Prairie Village, Kansas
Study site
Raleigh, North Carolina
Study site
Rochester Hills, Michigan
Study site
Saint Charles, Missouri
Study site
Santa Ana, California
Study site
Seattle, Washington
Study site
South Miami, Florida
Study site
St. Petersburg, Florida
Study site
Wharton, Texas
Study site
Wildomar, California
About this study
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
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).
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Atomoxetine 80 mg/d, Placebo, OROS methylphenidate HCl 54 mg/d, JNJ-31001074 3 mg/d, JNJ-31001074 1 mg/d
- Keywords
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders with Hyperactivity, Adult ADHD, JNJ-31001074
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atomoxetine 80 mg/dDrug
40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days
PlaceboDrug
Placebo capsule once daily for 42 days
OROS methylphenidate HCl 54 mg/dDrug
36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days
JNJ-31001074 3 mg/dDrug
3-mg capsule once daily for 42 days
JNJ-31001074 1 mg/dDrug
1-mg capsule once daily for 42 days
JNJ-31001074 10 mg/dDrug
10-mg capsule once daily for 42 days
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days Receives: Drug: JNJ-31001074 1 mg/d |
| 002 | Experimental | JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days Receives: Drug: JNJ-31001074 3 mg/d |
| 003 | Experimental | JNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days Receives: Drug: JNJ-31001074 10 mg/d |
| 004 | Active comparator | Atomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days Receives: Drug: Atomoxetine 80 mg/d |
| 005 | Active comparator | OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days Receives: Drug: OROS methylphenidate HCl 54 mg/d |
| 006 | Placebo comparator | Placebo capsule once daily for 42 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the ADHD rating scale total score
Measured: Through Day 42
Secondary outcomes (2)
Secondary endpoints will include Clinical Global Impression of Change (CGI-C).
Measured: 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).
Measured: Through the end of the double-blind treatment phase (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880217
- Sponsor's protocol ID
- CR015964
- Other IDs
- 31001074ATT2001
- Status last verified
- Feb 2013
- First submitted
- 9 Apr 2009
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22519922
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00880217
- Acronym / sponsor ID
- CR015964
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders with Hyperactivity, Adult ADHD, JNJ-31001074
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: JNJ-31001074 1 mg/dJNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days |
| 002 | Experimental | Drug: JNJ-31001074 3 mg/dJNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days |
| 003 | Experimental | Drug: JNJ-31001074 10 mg/dJNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days |
| 004 | Active comparator | Drug: Atomoxetine 80 mg/dAtomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days |
| 005 | Active comparator | Drug: OROS methylphenidate HCl 54 mg/dOROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days |
| 006 | Placebo comparator | Drug: PlaceboPlacebo capsule once daily for 42 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atomoxetine 80 mg/d40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days | Drug | 004 |
| PlaceboPlacebo capsule once daily for 42 days | Drug | 006 |
| OROS methylphenidate HCl 54 mg/d36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days | Drug | 005 |
| JNJ-31001074 3 mg/d3-mg capsule once daily for 42 days | Drug | 002 |
| JNJ-31001074 1 mg/d1-mg capsule once daily for 42 days | Drug | 001 |
| JNJ-31001074 10 mg/d10-mg capsule once daily for 42 days | Drug | 003 |
Primary outcome
Change from baseline in the ADHD rating scale total score
Time frame: Through Day 42
2 secondary outcomes
Secondary endpoints will include Clinical Global Impression of Change (CGI-C).
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Derived from this study: PubMed 22519922Weisler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atomoxetine 80 mg/d, OROS methylphenidate HCl 54 mg/d and JNJ-31001074 3 mg/d in people with Attention Deficit Hyperactivity Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the ADHD rating scale total score (time frame: Through Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00880217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2013.