Attention Deficit Disorder With HyperactivityPhase 4NCT00889915
Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)
A Phase 4 study testing Methylphenidate transdermal system, Lisdexamfetamine dimesylate and Osmotic-release oral system methylphenidate (OROS MPH) in people with Attention Deficit Disorder With Hyperactivity, run by Duke University at 1 site in United States.
Trial summary
This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Methylphenidate transdermal system, Lisdexamfetamine dimesylate and Osmotic-release oral system methylphenidate (OROS MPH)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV diagnostic criteria for ADHD combined, hyperactive/impulsive, or inattentive subtype
- Outpatient at study entry
- Speaks English
- Willing to be randomly assigned to one of the study treatment options as outlined in the protocol
- No known significant history of cardiovascular disorders, including pre-existing congenital heart disease, structural heart disease, known clinically significant electrocardiogram (ECG) abnormality, or other clinically significant cardiac disorder
- Willing to initiate study medication for ADHD within 7 days of the study baseline visit
- May be receiving stable treatment with other drug for a comorbid disorder, defined as no changes in dose or form of drug treatment for at least 2 weeks prior to the study enrollment visit
- May be receiving psychosocial interventions for ADHD or a comorbid disorder, defined as no changes in form of psychosocial treatment for at least 4 weeks prior to the study enrollment visit
Who cannot join
- Hypersensitivity to study medication
- Inpatient status at study entry
- Currently taking another medication for ADHD, including another psychostimulant, atomoxetine, or bupropion
- Receiving treatment with a tricyclic antidepressant at study enrollment, with the exception of low-dose imipramine for enuresis or amitriptyline for chronic pain
- Received treatment with a monoamine oxidase inhibitor (MAOI) within the past 30 days
- Psychostimulant drug dependence, bipolar disorder, or schizophrenia
Show all 14Show fewer
- Presence of psychosis
- Severe mental retardation
- Autism or Asperger's syndrome
- Active suicidal ideation
- Unable or unwilling to comply with the protocol
- Demonstrates a lack of benefit from, an intolerance to, or contraindication to psychostimulant medicine
- Presence of other clinically significant medical conditions, including hyperthyroidism, epilepsy or other seizure disorder, any condition for which an increase in blood pressure or heart rate would be problematic, glaucoma or other significant eye disease for which a psychostimulant would be problematic, or pre-existing gastrointestinal obstruction with gastrointestinal narrowing
- Pregnant or positive result of pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Child and Adolescent Psychiatry Trials Network (CAPTN)
Durham, North Carolina, 27710
About this study
Official title: A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended Release (Adderall XR) in Children and Adolescents With ADHD
This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD) is characterized by impulsiveness, hyperactivity, and inattention. It is seen primarily in children and adolescents and is often treated with psychostimulant medications. Osmotic-release oral system (OROS) methylphenidate, brand name Concerta, and mixed amphetamine salts extended release, brand name Adderall XR, are psychostimulant medications that have shown both efficacy (that they can have therapeutic benefits) and effectiveness (that they typically have therapeutic benefits in practice). Two newer psychostimulant medications-lisdexamfetamine dimesylate, brand name Vyvanse, and methylphenidate transdermal system, brand name Daytrana-have shown efficacy but have not been tested for effectiveness, nor have they been tested head-to-head against the older psychostimulants. This study will test the effectiveness, tolerability (lack of side effects), and acceptability (ease of use for patients) of the two newer psychostimulant medications and compare them to each other and to the two older psychostimulants.
Participation in this study will last 6 weeks, although some treatments may continue past the end of the study. At enrollment, participants will undergo a series of baseline evaluations. These will include interviews and assessments of ADHD symptoms, concurrent psychiatric disorders, medical and psychiatric history, family history of mental illness, risk and protective factors, other treatments, treatment expectancy of both the youth and parent, and vital signs. In consultation with their doctors, participants will be allowed to exclude zero, one, or two of the study medications; if they choose to exclude both of the new ADHD medications, they will not able to participate in the study. Participants will then be randomly assigned to one of the treatments they choose to include. They will receive a prescription for the medication and instructions for how to use it from their doctors; the study protocol does not specify a particular treatment regimen. Participants will undergo a second set of evaluations after 6 weeks of treatment or before, if the treatment ends earlier. This will include interviews and assessments similar to those administered at baseline as well as evaluation of any medication side effects.
- Being tested
- Methylphenidate transdermal system, Lisdexamfetamine dimesylate, Osmotic-release oral system methylphenidate (OROS MPH), Mixed amphetamine salts extended release
- Keywords
- ADHD, Methylphenidate, Amphetamine
- 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.
Methylphenidate transdermal systemDrug
Also called Daytrana
Not specified in protocol; determined by local standard of care.
Lisdexamfetamine dimesylateDrug
Also called Vyvanse
Not specified in protocol; determined by local standard of care.
Osmotic-release oral system methylphenidate (OROS MPH)Drug
Also called Concerta
Not specified in protocol; determined by local standard of care.
Mixed amphetamine salts extended releaseDrug
Also called Adderall XR
Not specified in protocol; determined by local standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive methylphenidate transdermal system. Receives: Drug: Methylphenidate transdermal system |
| 2 | Active comparator | Participants will receive lisdexamfetamine dimesylate. Receives: Drug: Lisdexamfetamine dimesylate |
| 3 | Active comparator | Participants will receive osmotic-release oral system methylphenidate (OROS MPH). Receives: Drug: Osmotic-release oral system methylphenidate (OROS MPH) |
| 4 | Active comparator | Participants will receive mixed amphetamine salts extended release. Receives: Drug: Mixed amphetamine salts extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale
The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group.
Measured: Measured at each participant's last visit, which can occur at or before Week 6
Secondary outcomes (2)
Clinical Global Impressions-Improvement (CGI-I) Scale
The CGI-I score at the subject's last study visit at or before Week 6, is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-I scale will be used to rate improvement in the subject's condition (benefits) since baseline using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; 7=very much worse.
Measured: Measured at each participant's last visit, which can occur at or before Week 6
Clinical Global Improvements-Acceptability (CGI-A) Scale
The CGI-A score at the subject's last study visit at or before Week 6 is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-A will be used to assess the acceptability of the study medication with respect to the subject's experience with the formulation of medication. The 7-point rating for the CGI-A will be: 1=very high acceptability, 2=high acceptability, 3=above average acceptability, 4=average acceptability, 5=low acceptability, 6=very low acceptability, 7=extremely low acceptability
Measured: Measured at each participant's last visit, which can occur at or before Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- John S. March, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889915
- Sponsor's protocol ID
- Pro00014075
- Other IDs
- P30MH066386-02, DSIR CTM 4571; Pro00014075
- Status last verified
- Jul 2013
- First submitted
- 27 Apr 2009
- Last updated
- 30 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended Release (Adderall XR) in Children and Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT00889915
- Acronym / sponsor ID
- Pro00014075
- Keywords
- ADHD, Methylphenidate, Amphetamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Posted 30 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder.
Detailed description
Attention deficit hyperactivity disorder (ADHD) is characterized by impulsiveness, hyperactivity, and inattention. It is seen primarily in children and adolescents and is often treated with psychostimulant medications. Osmotic-release oral system (OROS) methylphenidate, brand name Concerta, and mixed amphetamine salts extended release, brand name Adderall XR, are psychostimulant medications that have shown both efficacy (that they can have therapeutic benefits) and effectiveness (that they typically have therapeutic benefits in practice). Two newer psychostimulant medications-lisdexamfetamine dimesylate, brand name Vyvanse, and methylphenidate transdermal system, brand name Daytrana-have shown efficacy but have not been tested for effectiveness, nor have they been tested head-to-head against the older psychostimulants. This study will test the effectiveness, tolerability (lack of side effects), and acceptability (ease of use for patients) of the two newer psychostimulant medications and compare them to each other and to the two older psychostimulants.
Participation in this study will last 6 weeks, although some treatments may continue past the end of the study. At enrollment, participants will undergo a series of baseline evaluations. These will include interviews and assessments of ADHD symptoms, concurrent psychiatric disorders, medical and psychiatric history, family history of mental illness, risk and protective factors, other treatments, treatment expectancy of both the youth and parent, and vital signs. In consultation with their doctors, participants will be allowed to exclude zero, one, or two of the study medications; if they choose to exclude both of the new ADHD medications, they will not able to participate in the study. Participants will then be randomly assigned to one of the treatments they choose to include. They will receive a prescription for the medication and instructions for how to use it from their doctors; the study protocol does not specify a particular treatment regimen. Participants will undergo a second set of evaluations after 6 weeks of treatment or before, if the treatment ends earlier. This will include interviews and assessments similar to those administered at baseline as well as evaluation of any medication side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Methylphenidate transdermal systemParticipants will receive methylphenidate transdermal system. |
| 2 | Active comparator | Drug: Lisdexamfetamine dimesylateParticipants will receive lisdexamfetamine dimesylate. |
| 3 | Active comparator | Drug: Osmotic-release oral system methylphenidate (OROS MPH)Participants will receive osmotic-release oral system methylphenidate (OROS MPH). |
| 4 | Active comparator | Drug: Mixed amphetamine salts extended releaseParticipants will receive mixed amphetamine salts extended release. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Meets DSM-IV diagnostic criteria for ADHD combined, hyperactive/impulsive, or inattentive subtype
- Outpatient at study entry
- Speaks English
- Willing to be randomly assigned to one of the study treatment options as outlined in the protocol
- No known significant history of cardiovascular disorders, including pre-existing congenital heart disease, structural heart disease, known clinically significant electrocardiogram (ECG) abnormality, or other clinically significant cardiac disorder
Key exclusion criteria (14 listed)
- Hypersensitivity to study medication
- Inpatient status at study entry
- Currently taking another medication for ADHD, including another psychostimulant, atomoxetine, or bupropion
- Receiving treatment with a tricyclic antidepressant at study enrollment, with the exception of low-dose imipramine for enuresis or amitriptyline for chronic pain
- Received treatment with a monoamine oxidase inhibitor (MAOI) within the past 30 days
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 |
|---|---|---|
| Methylphenidate transdermal systemAlso: DaytranaNot specified in protocol; determined by local standard of care. | Drug | 1 |
| Lisdexamfetamine dimesylateAlso: VyvanseNot specified in protocol; determined by local standard of care. | Drug | 2 |
| Osmotic-release oral system methylphenidate (OROS MPH)Also: ConcertaNot specified in protocol; determined by local standard of care. | Drug | 3 |
| Mixed amphetamine salts extended releaseAlso: Adderall XRNot specified in protocol; determined by local standard of care. | Drug | 4 |
Primary outcome
Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale
Time frame: Measured at each participant's last visit, which can occur at or before Week 6
The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group.
2 secondary outcomes
Clinical Global Impressions-Improvement (CGI-I) Scale
Time frame: Measured at each participant's last visit, which can occur at or before Week 6
Clinical Global Improvements-Acceptability (CGI-A) Scale
Time frame: Measured at each participant's last visit, which can occur at or before Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for the Duke Clinical Research Institute Web siteLink provided by the sponsor.
- Click here for the American Academy of Child and Adolescent Psychiatry Web siteLink 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.
John S. March, MD, MPH principal investigator
Duke University
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 Methylphenidate transdermal system, Lisdexamfetamine dimesylate and Osmotic-release oral system methylphenidate (OROS MPH) in people with Attention Deficit Disorder With Hyperactivity, run by Duke University 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 8 inclusion and 14 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 30 Sep 2013. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale (time frame: Measured at each participant's last visit, which can occur at or before Week 6). 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 30 Sep 2013.