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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Protocol Summary:

      Effectiveness and Duration of Effect of Open Treatment in Adult ADHD Patients Treated with
      Lisdexamfetamine Dimesylate- LDX (Vyvanse)

      The primary objective of this study is to evaluate the effectiveness and duration of effect
      of LDX for the treatment of ADHD symptoms in adults. The study will be a 12-week open label
      extension with 25 adult participants who completed a cross-over study of adherence/efficacy
      of Adderall Immediate Release (IR) vs. Adderall Extended Release (XR).

      The secondary objective is to provide information regarding tolerability, dosing and
      titration of LDX in the adult population with ADHD.

      An additional fifteen participants will be recruited using advertising and previous Mental
      Health and Addictive Behaviour Research Program (MHADRP) studies will be offered treatment
      with LDX. All participants will be diagnosed with ADHD using the Adult Clinician Diagnostic
      Scale (ACDS). We will be collecting demographic information, administering the Scheduled
      Clinical Interview for DSM Disorders (SCID), collecting medical history, previous drug
      therapy, and the participant will have a physical with the physician. A coordinator will give
      an electrocardiogram (ECG), and collect a blood sample for blood chemistry and hematology.

      Schedule of Events: Vyvanse Extension Screening Visit

        -  Consent

        -  Demographics (needs to be added?)

        -  Physical

        -  Medical history (needs to be added?)

        -  Previous drug therapy

        -  Vitals (Blood Pressure-BP, Heart Rate-HR, Respiration, weight)

        -  Urine Drug screen

        -  Urine pregnancy test

        -  ECG

        -  Blood sample

        -  SCID

        -  ACDS

      Visits at week 0,1,2,3,4,6,8,10,12 (every visit)

        -  ADHD-Rating Scale (ADHD-RS)

        -  Adult ADHD Self-Report Scale (ASRS)

        -  Clinical Global Impression (CGI)

        -  Vitals

        -  Pill count

        -  Adverse Events (AE)/ Concomitant Medications (CM)

      Visits at week 0,1,4,6,12 also administer

        -  Adult ADHD Medication Rebound Scale (AMRS) (AM/PM)

        -  Adult ADHD Medication Smoothness of Effect Scale (AMSES) (AM/PM)

        -  Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADS) (AM/PM)

      First 4 weeks of treatment is a dose adjustment period (30-70 mg po qAM), after those 4 weeks
      established dose is remained for remaining 8 weeks of treatment.
    

Intervention name(s): LDX Treatment
Intervention type(s): Drug
Intervention description(s): 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Lisdexamfetamine Dimesylate; Amphetamine