Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: LDX Treatment
Intervention description: 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: ADHD; Lisdexamfetamine Dimesylate; Amphetamine

Summary:

      The purpose of this study is to examine the effectiveness and length of effect of Vyvanse on
      lessening Attention-Deficit/Hyperactivity Disorder symptoms in adults. The study will also
      investigate the safety and tolerability of Vyvanse in adults with ADHD.
    

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 all ADHD therapies for one week (psychostimulants) and three weeks
             (non-stimulants).

          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. Participants with a positive urine drug result at Screening.

          2. Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance
             abuse or dependence disorder (excluding nicotine).

          3. Participants with controlled depressive or anxiety disorders may not participate if,
             in the opinion of the Principal Investigator, their medications will interfere with
             safety or efficacy assessments.

          4. 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.

          5. Participants with hypertension at screening, indicated by a blood pressure reading of
             135/90 and heart rate above 120bmp.

          6. Female participants of childbearing potential who test positive for pregnancy at the
             time of enrollment based on a urine pregnancy test, or who do not 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.

          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 who in the investigator's opinion meet any of the exclusionary criteria
             specified on the FDA label of Vyvanse.