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
Intervention: Adderall ® Immediate Release; Adderall XR ®
Intervention description: 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.
Intervention MeSH terms: Adderall
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          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
             laboratory testing.

          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.

        Exclusion Criteria:

          1. Lifetime or present history of bipolar disorder, schizophrenia or schizoaffective
             disorder.

          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
             assessments.

          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.