A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

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.
    

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

           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.
    

Intervention name(s): Adderall ® Immediate Release; Adderall XR ®
Intervention type(s): Drug; Drug
Intervention description(s): 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 Extended Release (XR) was provided as treatment for three weeks at (15, 30, or 45 mg QD). The medication was optimized for titration.
Other intervention name(s): extended release adderall
Intervention MeSH terms: Adderall
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment