Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)
|ClinicalTrials.gov Identifier: NCT01070394|
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : November 25, 2016
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: LDX Treatment||Phase 4|
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
- Demographics (needs to be added?)
- Medical history (needs to be added?)
- Previous drug therapy
- Vitals (Blood Pressure-BP, Heart Rate-HR, Respiration, weight)
- Urine Drug screen
- Urine pregnancy test
- Blood sample
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)
- 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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Pharmacokinetics and Profile of Clinical Response of Subacute Lisdexamfetamine Dimesylate (Vyvanse) Treatment vs. Clinical Response to Subacute Immediate Release Mixed Amphetamine Salt Therapy in Adult ADHD|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Experimental: LDX Treatment
Eligible participants received 12 weeks of open-label treatment. Those on treatment prior to baseline underwent a 7-day (for amphetamine or methylphenidate) or 28-day (for atomoxetine or other medications) washout period prior to initiating LDX treatment. The starting dose was 30mg/day, which could be titrated up by 20mg/day during visits 2-6 (for a maximum dose of 70mg/day). At discretion of investigator, the dose could be down-titrated by 20mg/day during visits 4-6. Once the dose was optimized (after visit 6), the dose was maintained for 8 weeks.
Drug: LDX Treatment
30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.
Other Name: Vyvanse
- Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) [ Time Frame: 12 weeks ]
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
- Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS). [ Time Frame: Week 0 to Week 12 ]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.
- Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES) [ Time Frame: Visits 0 and 12 ]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).
- Correlation Between AMRS (In Clinic) and ADHD-RS [ Time Frame: Visits 0 and 12 ]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.
- Change in Correlation Between AMRS and TASS [ Time Frame: Visits 0 and 12 ]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.
- Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist [ Time Frame: Baseline to Week 12 ]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.
- Psychometric Validation of AMRS [ Time Frame: Weeks 0-12 ]To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.
- Psychometric Validation of AMSES [ Time Frame: Weeks 0-12 ]To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070394
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Lenard Adler, MD||NYU School of Medicine|