Effectiveness and Duration of Effect of Open Treatment in 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 : November 25, 2016
|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|
|Primary Completion Date :||July 2012|
|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
- ADHD-RS [ Time Frame: 12 weeks ]The ADHD-RS is a clinician-administered, semistructured scale that is designed to assess current symtomatology. It consists of 18 items that directly correspond to the DSM-IV symptoms of ADHD and each item is scored on a 4-pt scale ranging from 0 (none) to 3 (severe). It has been standardized to children but has been shown to be sensitive to drug effects in adults with ADHD. Presented will be the change in score of the ADHD-RS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).
- Symptom Rebound [ Time Frame: Visits 0 and 12 ]To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Presented will be the change in score of the AMRS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).
- Smoothness of Effect [ Time Frame: Visits 0 and 12 ]To evaluate smoothness of effect throughout a single day (assessed via the AMSES) of LDX treatment. Presented will be the change in score of the ADHD-RS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).
- 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. The Pearson's correlation coefficients for the In-Clinic assessment will be presented.
- 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.
- Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist [ Time Frame: Baseline to Week 12 ]To correlate symptom rebound throughout a single day (assessed via the AMRS, In Clinic) with a self-assessment of ADHD symptoms (the ASRS v.1.1 Symptom Checklist). Pearson's correlation coefficient will be presented.
- 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|