A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Adderall ┬« and Adderall XR ┬« (Drug)
Phase: Phase 4
Sponsored by: New York University School of Medicine
Official(s) and/or principal investigator(s):
Lenard Adler, MD, Principal Investigator, Affiliation: NYU School of Medicine
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.
Official title: A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Medication Event Monitoring System (MEMS┬«). Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed.
Medication Event Monitoring System (MEMS┬«). Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed.
Medication Event Monitoring System (MEMS┬«). Time adherence (MEMSt) is the percentage of doses taken within an interval compared to the total number of dosing intervals.
Dichotomous Measure of Nonadherence
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
o 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.
Minimum age: 18 Years.
Maximum age: 55 Years.
1. At the time of consent, are between the ages of 18-55, inclusive.
2. Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic
Scale (ACDS) v1. 2.
3. 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.
4. Must have a satisfactory medical assessment with no clinically significant
abnormalities as determined by medical history, physical exam, ECG, and clinical
5. Must be able to swallow capsules.
6. Must be able to begin the daily dose of study medication in the morning.
7. 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).
8. 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.
9. Must have given signed and dated informed consent in accordance with Good Clinical
Practice (GCP) Guidelines.
1. Lifetime or present history of bipolar disorder, schizophrenia or schizoaffective
2. 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
3. Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance
abuse or dependence disorder (excluding nicotine).
4. 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.
5. 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.
6. Participants with clinically significant ECG or laboratory abnormalities at screening
that are deemed exclusionary in the opinion of the Principal Investigator.
7. Participants who work the night shift or another schedule that would preclude
beginning the daily dose of study medication in the morning.
8. Participants with a positive urine drug result at Screening.
9. 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.
10. Participants with a history of structural cardiac abnormalities as well as any other
condition that may affect cardiac performance.
11. 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.
12. Participants who in the investigator's opinion meet any of the exclusionary criteria
specified on the FDA label of either Adderall or Adderall XR.
Locations and Contacts
VANYHHS, New York, New York 10010, United States
Starting date: August 2007
Last updated: March 11, 2013