Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
New York University School of Medicine |
---|---|
Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00468143 |
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.
Condition | Intervention | Phase |
---|---|---|
Attention Deficit Hyperactivity Disorder |
Drug: Adderall ® and Adderall XR ® |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall |
Estimated Enrollment: | 50 |
Study Start Date: | August 2007 |
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
Phase 2
Phase 3
Phase 4
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexis M Briggie | 212-686-7500 ext 3140 | alexis.briggie@nyumc.org |
United States, New York | |
VANYHHS | Recruiting |
New York, New York, United States, 10010 | |
Contact: Alexis M Briggie 212-686-7500 ext 3140 alexis.briggie@nyumc.org |
Principal Investigator: | Lenard Adler, MD | NYU School of Medicine |
Responsible Party: | NYU School of Medicine ( Lenard Adler, MD ) |
Study ID Numbers: | IR v XR |
Study First Received: | April 30, 2007 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00468143 History of Changes |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Adderall Mental Disorders Mental Disorders Diagnosed in Childhood |
Attention Deficit and Disruptive Behavior Disorders Neurologic Manifestations Hyperkinesis Central Nervous System Stimulants Dyskinesias |
Adderall Nervous System Diseases Physiological Effects of Drugs Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias Pharmacologic Actions Signs and Symptoms |
Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Central Nervous System Agents |