Attention Deficit Disorder With HyperactivityPhase 3NCT00557960
ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD
A Phase 3 study testing Mixed salts of a single-entity amphetamine and Atomoxetine hydrochloride in people with Attention Deficit Disorder With Hyperactivity, run by Shire at 1 site in United States.
Trial summary
Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator. Read more about this study
- Who is it for?
- Ages 19 to 25 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Mixed salts of a single-entity amphetamine and Atomoxetine hydrochloride
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2004to 25 Oct 2004
- Phase
- Phase 3
- 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 19 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary diagnosis of ADHD
- not naive to pharmacologic ADHD treatment
- valid driver's license with a minimum of 3 years driving experience
Who cannot join
- recent history of drug dependence or substance use disorder
- any specific cardiac condition that would, in the opinion of the investigator, require exclusion
- history of seizure in last 2 years, tic disorder or Tourette's disorder
- female subject is pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Neuropsychological Institute, LLC
Washington D.C., District of Columbia
About this study
Official title: A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.
- Being tested
- Mixed salts of a single-entity amphetamine, Atomoxetine hydrochloride
- 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.
Mixed salts of a single-entity amphetamineDrug
Also called ADDERALL XR
Atomoxetine hydrochlorideDrug
Also called STRATTERA
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Driving Safety Score derived by the driving simulator
Measured: Weeks 3 & 6
Secondary outcomes (3)
Driving Safety Scores at individual time points
Measured: 2, 7, and 12 hours post-dose at Weeks 3 & 6
Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
Measured: Weeks 3 & 6
AEs, laboratory screens, PE, vital signs, ECG
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study start25 Feb 2004
- Primary completion25 Oct 2004
- Study completion25 Oct 2004
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 Disorder With HyperactivityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557960
- Sponsor's protocol ID
- SLI381-316
- Status last verified
- May 2021
- First submitted
- 9 Nov 2007
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Kay GG, Michaels MA, Pakull B. Simulated driving changes in young adults with ADHD receiving mixed amphetamine salts extended release and atomoxetine. J Atten Disord. 2009 Jan;12(4):316-29. doi: 10.1177/1087054708322986. Epub 2008 Sep 24.
PubMed 18815438
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00557960
- Acronym / sponsor ID
- SLI381-316
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2004 (actual)
- Primary completion
- 25 Oct 2004 (actual)
- Study completion
- 25 Oct 2004 (actual)
- First posted
- 14 Nov 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.
Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- primary diagnosis of ADHD
- not naive to pharmacologic ADHD treatment
- valid driver's license with a minimum of 3 years driving experience
Key exclusion criteria (4 listed)
- recent history of drug dependence or substance use disorder
- any specific cardiac condition that would, in the opinion of the investigator, require exclusion
- history of seizure in last 2 years, tic disorder or Tourette's disorder
- female subject is pregnant or lactating
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 |
|---|---|---|
| Mixed salts of a single-entity amphetamineAlso: ADDERALL XR | Drug | – |
| Atomoxetine hydrochlorideAlso: STRATTERA | Drug | – |
Primary outcome
Overall Driving Safety Score derived by the driving simulator
Time frame: Weeks 3 & 6
3 secondary outcomes
Driving Safety Scores at individual time points
Time frame: 2, 7, and 12 hours post-dose at Weeks 3 & 6
Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
Time frame: Weeks 3 & 6
AEs, laboratory screens, PE, vital signs, ECG
Time frame: 6 weeks
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 25 May 2021.
- Results publication: PubMed 18815438Kay GG, Michaels MA, Pakull B. Simulated driving changes in young adults with ADHD receiving mixed amphetamine salts extended release and atomoxetine. J Atten Disord. 2009 Jan;12(4):316-29. doi: 10.1177/1087054708322986. Epub 2008 Sep 24.
- FDA Recall InformationLink provided by the sponsor.
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mixed salts of a single-entity amphetamine and Atomoxetine hydrochloride in people with Attention Deficit Disorder With Hyperactivity, run by Shire at 1 site 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 3 inclusion and 4 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall Driving Safety Score derived by the driving simulator (time frame: Weeks 3 & 6). 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 NCT00557960, 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 25 May 2021.