Attention Deficit Hyperactivity DisorderPhase 4NCT00468143
A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
A Phase 4 study testing Adderall ® Immediate Release and Adderall XR ® in people with Attention Deficit Hyperactivity Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this pilot study is to compare Adderall ® and Adderall XR ® in terms of their effectiveness and side effects for the treatment of ADHD in adults. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Adderall ® Immediate Release and Adderall XR ®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- At the time of consent, are between the ages of 18-55, inclusive.
- Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.2.
- Female participants of childbearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study. Females of childbearing potential are defined as women not surgically sterilized and are between menarche and 2 years post-menopause.
- Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing.
- Must be able to swallow capsules.
- Must be able to begin the daily dose of study medication in the morning.
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- Must be off previous amphetamine or methylphenidate treatment for 1 week prior to baseline (visit 2). Must be off past non-stimulant ADHD medication (i.e., atomoxetine) for 3 weeks prior to baseline (visit 2).
- In the opinion of the investigator, the subject must understand and be able, willing and likely to fully comply with the study procedures and restrictions.
- Must have given signed and dated informed consent in accordance with Good Clinical Practice (GCP) Guidelines.
Who cannot join
- Lifetime or present history of bipolar disorder, schizophrenia or schizoaffective disorder.
- Uncontrolled comorbid major depressive disorder, anxiety disorder or dysthymia. Participants with controlled depressive or anxiety disorders may participate if their medications have been stabilized for a minimum of four weeks and, in the opinion of the Principal Investigator, will not interfere with adherence, safety, or efficacy assessments.
- Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder (excluding nicotine).
- Have organic brain disease (such as dementia) or traumatic brain injury residua. Have a history of seizure disorder (other than febrile seizures) or participants who have taken (or are currently taking) anticonvulsants for seizure control.
- Females who are currently pregnant or breast feeding, and women of child-bearing potential who are not currently using an adequate form of birth control.
- Participants with clinically significant ECG or laboratory abnormalities at screening that are deemed exclusionary in the opinion of the Principal Investigator.
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- Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
- Participants with a positive urine drug result at Screening.
- Participants with any concurrent chronic or acute illness or unstable medical condition that could, in the opinion of the study physician, confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. Subjects who have a history of mental retardation or severe learning disability will be excluded.
- Participants with a history of structural cardiac abnormalities as well as any other condition that may affect cardiac performance.
- Participants with documented history of allergy, intolerance, or non-responsivity to methylphenidate or amphetamines. This includes a history of two or more failed stimulant treatment trials, as deemed by the Principal Investigator.
- Participants who in the investigator's opinion meet any of the exclusionary criteria specified on the FDA label of either Adderall or Adderall XR.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to compare Adderall ® and Adderall XR ® in terms of their effectiveness and side effects for the treatment of ADHD in adults.
Read the detailed description
This will be a randomized, cross-over study in which adults with ADHD will receive three weeks of treatment with Adderall (IR) (15, 30, or 45 mg TID) and three weeks of treatment of Adderall XR (XR) (15, 30, or 45 mg QD) for evaluation of dosing adherence and treatment efficacy. The order of the two conditions (TID-QD or QD-TID) will be counterbalanced across subjects, with a washout period in between treatment periods. Participants will be required to come to the site for 9 visits over approximately an 8-week period.
The study will consist of the following four phases:
- Phase 1
- Screening Visit (Visit 1)
- Treatment "A" Baseline Visit (Visit 2)
- Phase 2
- Treatment Period "A" - participants will take either Adderall or Adderall XR for 3 weeks (Visits 3-5)
- Phase 3
- 7-Day Washout Period - participants will be off Treatment "A" medication
- Treatment "B" Baseline visit (Visit 6)
- Phase 4 o Treatment Period "B" - participants will take either Adderall or Adderall XR for 3 weeks (Visits 7-9)
Eligible participants will be randomized in a 1:1 ratio to one of two schedules of treatment, Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR. Within both schedules, each treatment will consist of a 3-week dose optimization titration evaluation period with a washout week prior to switching to the second respective treatment. The maximum total daily dose will be 45mg, with 15mg TID for IR or 45mg QD for XR. Throughout the medication treatment periods, participants will visit the clinic weekly for evaluations of efficacy, tolerance, and adherence. Medical evaluations will also be conducted at each treatment visit, including assessment of weight, blood pressure, and pulse. Efficacy and adherence data will collected by separate research staff, so that the rater evaluating efficacy will be blinded to the adherence results. The clinician evaluating efficacy will also be blinded to the participants' treatment assignment.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Adderall ® Immediate Release, Adderall XR ®
- 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.
Adderall ® Immediate ReleaseDrug
Adderall Immediate release (IR) was provided as treatment for three weeks (at 15, 30 or 45 mg TID). The medication was optimized for titration.
Adderall XR ®Drug
Also called extended release adderall
Adderall Extended Release (XR) was provided as treatment for three weeks at (15, 30, or 45 mg QD). The medication was optimized for titration.
| Study group | Role | What they receive |
|---|---|---|
| Adderall Extended Release First | Experimental | This group was treated with Adderall extended release, either during phase 2 of the trial, or during phase 3 (this subset received Adderall immediate release during phase 2 and then underwent a washout period). This was a counterbalanced crossover study, with a washout period in between treatment periods. Participants were randomized in a 1:1 ratio to one of two schedules Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR. Receives: Drug: Adderall ® Immediate Release; Drug: Adderall XR ® |
| Adderall Immediate Release First | Experimental | This group was treated with Adderall immediate release, either during phase 2 of the trial, or during phase 3 (this subset received Adderall extended release during phase 2 and then underwent a washout period). This was a counterbalanced crossover study, with a washout period in between treatment periods. Participants were randomized in a 1:1 ratio to one of two schedules Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR. Receives: Drug: Adderall ® Immediate Release; Drug: Adderall XR ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Event Monitoring System (MEMS®) Dosage Adherence
Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.
Measured: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Medication Event Monitoring System (MEMS®) Regimen Adherence
Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent.
Measured: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Medication Event Monitoring System (MEMS®) Time Adherence
Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent.
Measured: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Secondary outcomes (2)
Pill Count
Study staff counted unused medication at each weekly visit to yield a percentage of prescribed pills that were consumed. For each group, the number given will be the total number of consumed pills divided by total number of pill prescribed.
Measured: At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Self Report
Self-reported adherence was ascertained via retrospective self-report of daily regimen adherence. Participants were considered adherent for Adderall IR (Methamphetamine salts) if they took the first does in the morning within 30 minutes of waking, and then each subsequent dose in 5-hour intervals (within 30 minutes). For Adderall XR (Methamphetamine salts), participants were considered adherent if they took the single daily dose in the morning within 30 minutes of waking. The number given below represents the total number of self-reported adherent participants divided by the total number of participants per group, times 100 (to obtain percentage).
Measured: At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2009
- Study completionJan 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.
- 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.
- More trials run by NYU Langone HealthThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lenard Adler, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468143
- Sponsor's protocol ID
- IR v XR
- Status last verified
- Apr 2016
- First submitted
- 30 Apr 2007
- Last updated
- 2 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Adler LA, Lynch LR, Shaw DM, Wallace SP, Ciranni MA, Briggie AM, Kulaga A, O'Donnell KE, Faraone SV. Medication adherence and symptom reduction in adults treated with mixed amphetamine salts in a randomized crossover study. Postgrad Med. 2011 Sep;123(5):71-9. doi: 10.3810/pgm.2011.09.2461.
PubMed 21904088
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
- ClinicalTrials.gov ID
- NCT00468143
- Acronym / sponsor ID
- IR v XR
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 2 May 2007 (estimated)
- Results
- Posted 2 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to compare Adderall ® and Adderall XR ® in terms of their effectiveness and side effects for the treatment of ADHD in adults.
Detailed description
This will be a randomized, cross-over study in which adults with ADHD will receive three weeks of treatment with Adderall (IR) (15, 30, or 45 mg TID) and three weeks of treatment of Adderall XR (XR) (15, 30, or 45 mg QD) for evaluation of dosing adherence and treatment efficacy. The order of the two conditions (TID-QD or QD-TID) will be counterbalanced across subjects, with a washout period in between treatment periods. Participants will be required to come to the site for 9 visits over approximately an 8-week period.
The study will consist of the following four phases:
- Phase 1
- Screening Visit (Visit 1)
- Treatment "A" Baseline Visit (Visit 2)
- Phase 2
- Treatment Period "A" - participants will take either Adderall or Adderall XR for 3 weeks (Visits 3-5)
- Phase 3
- 7-Day Washout Period - participants will be off Treatment "A" medication
- Treatment "B" Baseline visit (Visit 6)
- Phase 4 o Treatment Period "B" - participants will take either Adderall or Adderall XR for 3 weeks (Visits 7-9)
Eligible participants will be randomized in a 1:1 ratio to one of two schedules of treatment, Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR. Within both schedules, each treatment will consist of a 3-week dose optimization titration evaluation period with a washout week prior to switching to the second respective treatment. The maximum total daily dose will be 45mg, with 15mg TID for IR or 45mg QD for XR. Throughout the medication treatment periods, participants will visit the clinic weekly for evaluations of efficacy, tolerance, and adherence. Medical evaluations will also be conducted at each treatment visit, including assessment of weight, blood pressure, and pulse. Efficacy and adherence data will collected by separate research staff, so that the rater evaluating efficacy will be blinded to the adherence results. The clinician evaluating efficacy will also be blinded to the participants' treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adderall Extended Release First | Experimental | Drug: Adderall ® Immediate Release, Drug: Adderall XR ®This group was treated with Adderall extended release, either during phase 2 of the trial, or during phase 3 (this subset received Adderall immediate release during phase 2 and then underwent a washout period). This was a counterbalanced crossover study, with a washout period in between treatment periods. Participants were randomized in a 1:1 ratio to one of two schedules Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR. |
| Adderall Immediate Release First | Experimental | Drug: Adderall ® Immediate Release, Drug: Adderall XR ®This group was treated with Adderall immediate release, either during phase 2 of the trial, or during phase 3 (this subset received Adderall extended release during phase 2 and then underwent a washout period). This was a counterbalanced crossover study, with a washout period in between treatment periods. Participants were randomized in a 1:1 ratio to one of two schedules Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- At the time of consent, are between the ages of 18-55, inclusive.
- Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.2.
- Female participants of childbearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study. Females of childbearing potential are defined as women not surgically sterilized and are between menarche and 2 years post-menopause.
- Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing.
- Must be able to swallow capsules.
Key exclusion criteria (12 listed)
- Lifetime or present history of bipolar disorder, schizophrenia or schizoaffective disorder.
- Uncontrolled comorbid major depressive disorder, anxiety disorder or dysthymia. Participants with controlled depressive or anxiety disorders may participate if their medications have been stabilized for a minimum of four weeks and, in the opinion of the Principal Investigator, will not interfere with adherence, safety, or efficacy assessments.
- Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder (excluding nicotine).
- Have organic brain disease (such as dementia) or traumatic brain injury residua. Have a history of seizure disorder (other than febrile seizures) or participants who have taken (or are currently taking) anticonvulsants for seizure control.
- Females who are currently pregnant or breast feeding, and women of child-bearing potential who are not currently using an adequate form of birth control.
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 |
|---|---|---|
| Adderall ® Immediate ReleaseAdderall Immediate release (IR) was provided as treatment for three weeks (at 15, 30 or 45 mg TID). The medication was optimized for titration. | Drug | Adderall Extended Release First, Adderall Immediate Release First |
| Adderall XR ®Also: extended release adderallAdderall Extended Release (XR) was provided as treatment for three weeks at (15, 30, or 45 mg QD). The medication was optimized for titration. | Drug | Adderall Extended Release First, Adderall Immediate Release First |
Primary outcome
Medication Event Monitoring System (MEMS®) Dosage Adherence
Time frame: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.
Medication Event Monitoring System (MEMS®) Regimen Adherence
Time frame: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent.
Medication Event Monitoring System (MEMS®) Time Adherence
Time frame: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent.
2 secondary outcomes
Pill Count
Time frame: At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Self Report
Time frame: At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21904088Adler LA, Lynch LR, Shaw DM, Wallace SP, Ciranni MA, Briggie AM, Kulaga A, O'Donnell KE, Faraone SV. Medication adherence and symptom reduction in adults treated with mixed amphetamine salts in a randomized crossover study. Postgrad Med. 2011 Sep;123(5):71-9. doi: 10.3810/pgm.2011.09.2461.
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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.
Lenard Adler, MD principal investigator
NYU School of Medicine
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 Adderall ® Immediate Release and Adderall XR ® in people with Attention Deficit Hyperactivity Disorder, run by NYU Langone Health 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 9 inclusion and 12 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 Jun 2016. 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 2 Jun 2016). 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?
Medication Event Monitoring System (MEMS®) Dosage Adherence (time frame: The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)). The study lists 3 primary outcomes in all. 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 NCT00468143, 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 2 Jun 2016.