Back to resultsEffectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LDX Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Lisdexamfetamine Dimesylate, Amphetamine
Eligibility Criteria
Inclusion Criteria:
- At the time of consent, are between the ages of 18-55, inclusive.
- Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.2.
- 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.
- Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing.
- Must be able to swallow capsules.
- Must be able to begin the daily dose of study medication in the morning.
- Must be off all ADHD therapies for one week (psychostimulants) and three weeks (non-stimulants).
- 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.
- Must have given signed and dated informed consent in accordance with Good Clinical Practice (GCP) Guidelines.
Exclusion Criteria:
- Participants with a positive urine drug result at Screening.
- Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder (excluding nicotine).
- 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.
- 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.
- Participants with hypertension at screening, indicated by a blood pressure reading of 135/90 and heart rate above 120bmp.
- 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.
- Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
- Participants who in the investigator's opinion meet any of the exclusionary criteria specified on the FDA label of Vyvanse.
Sites / Locations
- NYU School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LDX Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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).
Correlation Between AMRS (In Clinic) and ADHD-RS
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
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
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
To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.
Psychometric Validation of AMSES
To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.
Full Information
NCT ID
NCT01070394
First Posted
February 16, 2010
Last Updated
March 5, 2018
Sponsor
NYU Langone Health
Collaborators
Shire
1. Study Identification
Unique Protocol Identification Number
NCT01070394
Brief Title
Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Shire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Lisdexamfetamine Dimesylate, Amphetamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LDX Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LDX Treatment
Other Intervention Name(s)
Vyvanse
Intervention Description
30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.
Primary Outcome Measure Information:
Title
Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)
Description
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
Secondary Outcome Measure Information:
Title
Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS).
Description
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
Title
Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES)
Description
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
Title
Correlation Between AMRS (In Clinic) and ADHD-RS
Description
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
Title
Change in Correlation Between AMRS and TASS
Description
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
Title
Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist
Description
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
Title
Psychometric Validation of AMRS
Description
To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.
Time Frame
Weeks 0-12
Title
Psychometric Validation of AMSES
Description
To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.
Time Frame
Weeks 0-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At the time of consent, are between the ages of 18-55, inclusive.
Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.2.
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.
Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing.
Must be able to swallow capsules.
Must be able to begin the daily dose of study medication in the morning.
Must be off all ADHD therapies for one week (psychostimulants) and three weeks (non-stimulants).
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.
Must have given signed and dated informed consent in accordance with Good Clinical Practice (GCP) Guidelines.
Exclusion Criteria:
Participants with a positive urine drug result at Screening.
Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder (excluding nicotine).
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.
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.
Participants with hypertension at screening, indicated by a blood pressure reading of 135/90 and heart rate above 120bmp.
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.
Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
Participants who in the investigator's opinion meet any of the exclusionary criteria specified on the FDA label of Vyvanse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lenard Adler, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25295646
Citation
Adler LA, Alperin S, Leon T, Faraone S. Clinical effects of lisdexamfetamine and mixed amphetamine salts immediate release in adult ADHD: results of a crossover design clinical trial. Postgrad Med. 2014 Sep;126(5):17-24. doi: 10.3810/pgm.2014.09.2796.
Results Reference
derived
PubMed Identifier
23356790
Citation
Mattingly GW, Weisler RH, Young J, Adeyi B, Dirks B, Babcock T, Lasser R, Scheckner B, Goodman DW. Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. BMC Psychiatry. 2013 Jan 29;13:39. doi: 10.1186/1471-244X-13-39.
Results Reference
derived
Learn more about this trial
Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)
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