Attention-Deficit/Hyperactivity DisorderPhase 2NCT00429091
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing ABT-894 and atomoxetine in people with Attention-Deficit/Hyperactivity Disorder and ADHD, run by Abbott at 22 sites in United States.
Trial summary
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder, ADHD
- What is being tested?
- ABT-894 and atomoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 22 sitesUnited States
- Study dates
- Jan 2007to Aug 2007
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet criteria for attention-deficit/hyperactivity disorder
- Have voluntarily signed an informed form
- Are between 18 and 60 years of age
- Will use contraceptive methods during the study
- Women must not be pregnant or breast-feeding
- Must be in generally good health
- Are fluent in English
Who cannot join
- They have a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder or mental retardation
- They have a current diagnosis of major depressive episode, generalized anxiety disorder (GAD), or post-traumatic stress disorder (PTSD) or has a clinically significant sleep disorder requiring treatment
- They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants, mood stabilizers, nicotine replacement therapies or varenicline
- They require ongoing treatment or expected treatment with Coumadin
- They failed to respond to two or more adequate trials of FDA-approved ADHD medication
- They have taken atomoxetine during the last 3 months
Show all 10Show fewer
- They have violent, homicidal or suicidal ideation
- They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome, traumatic brain injury, or a central nervous system (CNS) disease, excluding ADHD
- They have a urine drug screen that is positive for alcohol or drugs of abuse
- They have a history of substance or alcohol disorder during the last 3 months
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Site Reference ID/Investigator# 5972
Austin, Texas, 78756
Site Reference ID/Investigator# 5959
Bellaire, Texas, 77401
Site Reference ID/Investigator# 5958
Bellevue, Washington, 98007
Site Reference ID/Investigator# 5962
Boston, Massachusetts, 02114
Site Reference ID/Investigator# 5964
Burlington, Vermont, 05401
Site Reference ID/Investigator# 5957
Charleston, South Carolina, 29407
Site Reference ID/Investigator# 5963
Charlotte, North Carolina, 28211
Site Reference ID/Investigator# 5960
Clementon, New Jersey, 08021
Site Reference ID/Investigator# 5975
Eugene, Oregon, 97401
Site Reference ID/Investigator# 5973
Libertyville, Illinois, 60048
Site Reference ID/Investigator# 5954
Okemos, Michigan, 48864
Site Reference ID/Investigator# 5974
Orlando, Florida, 32806
Site Reference ID/Investigator# 5968
Overland Park, Kansas, 66212
Site Reference ID/Investigator# 5971
Philadelphia, Pennsylvania, 19149
Site Reference ID/Investigator# 5952
Rockville, Maryland, 20852
Site Reference ID/Investigator# 5951
Salt Lake City, Utah, 84107
Site Reference ID/Investigator# 5969
San Antonio, Texas, 78258
Site Reference ID/Investigator# 5965
San Francisco, California, 94143-0984
Site Reference ID/Investigator# 5970
Troy, Michigan, 48085
Site Reference ID/Investigator# 5953
Virginia Beach, Virginia, 23452
Site Reference ID/Investigator# 5956
West Palm Beach, Florida, 33407
Site Reference ID/Investigator# 5955
Wildomar, California, 92595
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)
- Conditions
- Attention-Deficit/Hyperactivity Disorder, ADHD
- Being tested
- ABT-894, atomoxetine, placebo
- 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.
ABT-894Drug
Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
atomoxetineDrug
Subjects will take 40 mg BID or placebo for up to four weeks.
placeboDrug
Subjects will take BID for up to four weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: placebo |
| 2 | Experimental | Not described Receives: Drug: ABT-894 |
| 3 | Active comparator | Not described Receives: Drug: atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)
Measured: Final Evaluation of each 4-week Treatment Period
Secondary outcomes (9)
CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores
Measured: Final Evaluation of each 4-week Treatment Period
CAARS ADHD Index
Measured: Final Evaluation of each 4-week Treatment Period
CGI-ADHD-S
Measured: Final Evaluation of each 4-week Treatment Period
AISRS
Measured: Final Evaluation of each 4-week Treatment Period
CAARS:Self
Measured: Final Evaluation of each 4-week Treatment Period
TASS
Measured: Final Evaluation of each 4-week Treatment Period
FTND
Measured: Final Evaluation of each 4-week Treatment Period
QSU-Brief
Measured: Final Evaluation of each 4-week Treatment Period
CANTAB cognitive battery
Measured: Final Evaluation of each 4-week Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Earle Bain, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429091
- Sponsor's protocol ID
- M06-818
- Status last verified
- Sep 2010
- First submitted
- 29 Jan 2007
- Last updated
- 2 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00429091
- Acronym / sponsor ID
- M06-818
- Conditions
- Attention-Deficit/Hyperactivity Disorder, ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2007 (actual)
- First posted
- 31 Jan 2007 (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.
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo |
| 2 | Experimental | Drug: ABT-894 |
| 3 | Active comparator | Drug: atomoxetine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meet criteria for attention-deficit/hyperactivity disorder
- Have voluntarily signed an informed form
- Are between 18 and 60 years of age
- Will use contraceptive methods during the study
- Women must not be pregnant or breast-feeding
Key exclusion criteria (10 listed)
- They have a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder or mental retardation
- They have a current diagnosis of major depressive episode, generalized anxiety disorder (GAD), or post-traumatic stress disorder (PTSD) or has a clinically significant sleep disorder requiring treatment
- They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants, mood stabilizers, nicotine replacement therapies or varenicline
- They require ongoing treatment or expected treatment with Coumadin
- They failed to respond to two or more adequate trials of FDA-approved ADHD medication
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 |
|---|---|---|
| ABT-894Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks. | Drug | 2 |
| atomoxetineSubjects will take 40 mg BID or placebo for up to four weeks. | Drug | 3 |
| placeboSubjects will take BID for up to four weeks | Drug | 1 |
Primary outcome
CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)
Time frame: Final Evaluation of each 4-week Treatment Period
9 secondary outcomes
CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores
Time frame: Final Evaluation of each 4-week Treatment Period
CAARS ADHD Index
Time frame: Final Evaluation of each 4-week Treatment Period
CGI-ADHD-S
Time frame: Final Evaluation of each 4-week Treatment Period
AISRS
Time frame: Final Evaluation of each 4-week Treatment Period
CAARS:Self
Time frame: Final Evaluation of each 4-week Treatment Period
TASS
Time frame: Final Evaluation of each 4-week Treatment Period
FTND
Time frame: Final Evaluation of each 4-week Treatment Period
QSU-Brief
Time frame: Final Evaluation of each 4-week Treatment Period
CANTAB cognitive battery
Time frame: Final Evaluation of each 4-week Treatment Period
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 2 Nov 2010.
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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.
Earle Bain, MD study director
Abbott
22 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 ABT-894 and atomoxetine in people with Attention-Deficit/Hyperactivity Disorder and ADHD, run by Abbott at 22 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 7 inclusion and 10 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 2 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales) (time frame: Final Evaluation of each 4-week Treatment Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2010.