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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.
NYU School of Medicine
New York, New York, United States
Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)
The ADHD-RS with adult ADHD prompts is a semi-structured scale that consists of 18 items that directly correspond to the 18 DSM-IV symptoms of ADHD, and is designed to assess current symptomatology19. Each item is scored on a 4-point scale ranging from 0 (none) to 3 (severe).Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. A score of 0-16 means "Unlikely to have ADHD"; a score of 17-23 "Likely to Have ADHD" ; 24 or greater-Highly Likely to have ADHD
Time frame: 12 weeks
Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS).
To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Scoring on the AMRS based on 38 items, each scored 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe). The lowest scored units on a scale for 1 individual is 0, the highest 114. The scores reported below are Mean scores for 33 patients analyzed.
Time frame: Week 0 to Week 12
Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES)
The Adult ADHD Medication Smoothness of Effect Scale (AMSES) is a 6-item, frequency-based, self-report scale that was recently developed to assess the consistency and duration of effect of ADHD medication throughout the day. The AMSES compares the effectiveness of ADHD medication shortly after dosing with the effectiveness later in the day. Respondents are asked to rate how frequently the effective-ness of their medication was the same 2 hr post-dose as it was 4, 6, 8, 10, and 12 hr post-dose on a 0 to 4 scale (0 = never, 1 = rarel, 2 = sometimes, 3 = often, 4 = very often). In addition, respondents rate how frequently the delivery of their medication was consistent and smooth throughout the day on a visual analog scale ranging from 0 (never) to 100 (very often).
Time frame: Visits 0 and 12
Correlation Between AMRS (In Clinic) and ADHD-RS
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To correlate symptom rebound through a single day (assessed via the AMRS) with a global (ADHD-RS) measure of efficacy of LDX treatment. AMRS and ADHD-RD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.
Time frame: Visits 0 and 12
Change in Correlation Between AMRS and TASS
To correlate symptom rebound through a single day (assessed via the AMRS) with a time-sensitive (TASS) measure of efficacy of LDX treatment. A Pearson's correlation coefficient will be presented. AMRS and TASS scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.
Time frame: Visits 0 and 12
Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist
To correlate symptom rebound through a single day (assessed via the AMRS) with a self assessment of ADHD Symptoms. A Pearson's correlation coefficient will be presented. AMRS and self assessment of ADHD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.
Time frame: Baseline to Week 12
Psychometric Validation of AMRS
To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.
Time frame: Weeks 0-12
Psychometric Validation of AMSES
To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.
Time frame: Weeks 0-12