Attention-Deficit/Hyperactivity DisorderPhase 2NCT00391729
A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing ABT-089 in people with Attention-Deficit/Hyperactivity Disorder, run by Abbott at 23 sites in United States.
Trial summary
The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- ABT-089
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 23 sitesUnited States
- Study dates
- Oct 2006to Jun 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 consent 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 have a clinically significant sleep disorder requiring treatment
- They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers
- They failed to respond to two or more adequate trials of FDA-approved ADHD medication
- They have violent, homicidal or suicidal ideation
- They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome 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 (abuse/dependence) during the last 3 months
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Study site
Bridgewater, New Jersey, 10312
Study site
Chapel Hill, North Carolina, 27514
Study site
Charleston, South Carolina, 29405
Study site
Denver, Colorado, 80212
Study site
Farmington Hills, Michigan, 48336
Study site
Herndon, Virginia, 20170
Study site
Jacksonville, Florida, 32216
Study site
Lafayette, California, 94549
Study site
Lake Jackson, Texas, 77566
Study site
Lyndhurst, Ohio, 44124
Study site
Maitland, Florida, 32751
Study site
Memphis, Tennessee, 38119
Study site
Mesa, Arizona, 85210
Study site
Miami, Florida, 33173
Study site
Middleton, Wisconsin, 53562
Study site
New York, New York, 10010
Study site
Newton, Kansas, 67114
Study site
Oceanside, California, 92056
Study site
Omaha, Nebraska, 68198
Study site
Portland, Oregon, 97210
Study site
San Diego, California, 92103
Study site
Staten Island, New York, 10312
Study site
Tampa, Florida, 33606
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- ABT-089, Placebo
- Keywords
- ADHD
- 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-089Drug
Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks
PlaceboDrug
Subjects will take placebo QD, BID for 4-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: ABT-089 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
Measured: at the final evaluation of each 4-week treatment period
Secondary outcomes (4)
CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores
Measured: at the final evaluation of each 4-week treatment period
CAARS ADHD Index, CAARS:Self
Measured: at the final evaluation of each 4-week treatment period
CGI-ADHD-S, AISRS, TASS, FTND
Measured: at the final evaluation of each 4-week treatment period
QSU-Brief, CANTAB cognitive battery
Measured: at the 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 posted24 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Gault, MD,PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391729
- Sponsor's protocol ID
- M06-855
- Status last verified
- Oct 2011
- First submitted
- 20 Oct 2006
- Last updated
- 18 Oct 2011
- Results posted
- No
Publications
Apostol G, Abi-Saab W, Kratochvil CJ, Adler LA, Robieson WZ, Gault LM, Pritchett YL, Feifel D, Collins MA, Saltarelli MD. Efficacy and safety of the novel alpha(4)beta(2) neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study. Psychopharmacology (Berl). 2012 Feb;219(3):715-25. doi: 10.1007/s00213-011-2393-2. Epub 2011 Jul 12.
PubMed 21748252
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. 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-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00391729
- Acronym / sponsor ID
- M06-855
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 24 Oct 2006 (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 objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: ABT-089 |
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 consent 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 (8 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 have a clinically significant sleep disorder requiring treatment
- They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers
- They failed to respond to two or more adequate trials of FDA-approved ADHD medication
- They have violent, homicidal or suicidal ideation
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-089Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks | Drug | 2 |
| PlaceboSubjects will take placebo QD, BID for 4-6 weeks | Drug | 1 |
Primary outcome
Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score
Time frame: at the final evaluation of each 4-week treatment period
4 secondary outcomes
CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores
Time frame: at the final evaluation of each 4-week treatment period
CAARS ADHD Index, CAARS:Self
Time frame: at the final evaluation of each 4-week treatment period
CGI-ADHD-S, AISRS, TASS, FTND
Time frame: at the final evaluation of each 4-week treatment period
QSU-Brief, CANTAB cognitive battery
Time frame: at the 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 18 Oct 2011.
- Derived from this study: PubMed 21748252Apostol G, Abi-Saab W, Kratochvil CJ, Adler LA, Robieson WZ, Gault LM, Pritchett YL, Feifel D, Collins MA, Saltarelli MD. Efficacy and safety of the novel alpha(4)beta(2) neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study. Psychopharmacology (Berl). 2012 Feb;219(3):715-25. doi: 10.1007/s00213-011-2393-2. Epub 2011 Jul 12.
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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.
Laura Gault, MD,PhD study director
Abbott
23 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-089 in people with Attention-Deficit/Hyperactivity Disorder, run by Abbott at 23 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 8 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 18 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score (time frame: at the 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?
On the ClinicalTrials.gov record for NCT00391729, 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 18 Oct 2011.