Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)

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.

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.