ADHDPhase 4NCT00506727
Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
A Phase 4 study testing Mixed amphetamine salts (ADDERALL XR) and Atomoxetine hydrochloride in people with ADHD, run by Shire at 1 site in United States.
Trial summary
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Mixed amphetamine salts (ADDERALL XR) and Atomoxetine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2003to 2 Jul 2004
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary diagnosis of ADHD combined subtype or predominantly hyperactive-impulsive subtype, based on psychiatric evaluation
- Capable of understanding and following classroom instructions
- Generally functioning academically at age-appropriate levels
Who cannot join
- ADHD, predominantly inattentive subtype
- Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD, severe depressive or severe anxiety disorder
- Documented history of aggressive behavior serious enough to preclude participation in regular classroom activities
- Documented allergies or intolerance to either of the active treatments or tricyclic antidepressants
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Analog Classroom Study, Evaluating ADDERALL XR Versus STRATTERA, Dosed Once Daily, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD)
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.
- Conditions
- ADHD
- Being tested
- Mixed amphetamine salts (ADDERALL XR), 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 amphetamine salts (ADDERALL XR)Drug
Atomoxetine hydrochlorideDrug
Also called Strattera
| Study group | Role | What they receive |
|---|---|---|
| Adderall XR | Experimental | Not described Receives: Drug: Mixed amphetamine salts (ADDERALL XR) |
| Atomoxetine hydrochloride | Active comparator | Not described Receives: Drug: Atomoxetine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)
Measured: Approximately 3 weeks
Secondary outcomes (2)
PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL
Measured: Approximately 3 weeks
treatment-emergent adverse events
Measured: approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study start5 Aug 2003
- Primary completion2 Jul 2004
- Study completion2 Jul 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 ADHDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 215 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
- NCT00506727
- Sponsor's protocol ID
- SLI381-404
- Status last verified
- Jun 2021
- First submitted
- 19 Jul 2007
- Last updated
- 8 Jun 2021
- Results posted
- No
Publications
Wigal SB, McGough JJ, McCracken JT, Biederman J, Spencer TJ, Posner KL, Wigal TL, Kollins SH, Clark TM, Mays DA, Zhang Y, Tulloch SJ. A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder. J Atten Disord. 2005 Aug;9(1):275-89. doi: 10.1177/1087054705281121.
PubMed 16371674
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Analog Classroom Study, Evaluating ADDERALL XR Versus STRATTERA, Dosed Once Daily, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00506727
- Acronym / sponsor ID
- SLI381-404
- Conditions
- ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2003 (actual)
- Primary completion
- 2 Jul 2004 (actual)
- Study completion
- 2 Jul 2004 (actual)
- First posted
- 25 Jul 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 behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adderall XR | Experimental | Drug: Mixed amphetamine salts (ADDERALL XR) |
| Atomoxetine hydrochloride | Active comparator | Drug: Atomoxetine hydrochloride |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Primary diagnosis of ADHD combined subtype or predominantly hyperactive-impulsive subtype, based on psychiatric evaluation
- Capable of understanding and following classroom instructions
- Generally functioning academically at age-appropriate levels
Key exclusion criteria (4 listed)
- ADHD, predominantly inattentive subtype
- Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD, severe depressive or severe anxiety disorder
- Documented history of aggressive behavior serious enough to preclude participation in regular classroom activities
- Documented allergies or intolerance to either of the active treatments or tricyclic antidepressants
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 amphetamine salts (ADDERALL XR) | Drug | Adderall XR |
| Atomoxetine hydrochlorideAlso: Strattera | Drug | Atomoxetine hydrochloride |
Primary outcome
Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)
Time frame: Approximately 3 weeks
2 secondary outcomes
PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL
Time frame: Approximately 3 weeks
treatment-emergent adverse events
Time frame: approximately 3 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 8 Jun 2021.
- Results publication: PubMed 16371674Wigal SB, McGough JJ, McCracken JT, Biederman J, Spencer TJ, Posner KL, Wigal TL, Kollins SH, Clark TM, Mays DA, Zhang Y, Tulloch SJ. A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder. J Atten Disord. 2005 Aug;9(1):275-89. doi: 10.1177/1087054705281121.
- FDA-approved labelling information, US onlyLink provided by the sponsor.
- FDA Recall informationLink provided by the sponsor.
Related trials for ADHD
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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 4 study testing Mixed amphetamine salts (ADDERALL XR) and Atomoxetine hydrochloride in people with ADHD, 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 8 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21) (time frame: Approximately 3 weeks). 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 NCT00506727, 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 8 Jun 2021.