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

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ClinicalTrials.gov Identifier: NCT01070394
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : November 25, 2016
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: LDX Treatment
Enrollment 40
Recruitment Details The first 25 participants enrolled consisted of adults who had recently completed a randomized, cross-over, open label study (MAS Adherence Study) that examined adherence to ADHD treatment with MAS IR vs. MAS XR. An additional 15 adults were recruited from local advertising and from the pool of participants at the MHADRP at the NYU SoM.
Pre-assignment Details Participants taking prohibited concomitant medications, including ADHD medications, will be required to washout of their medication during the screening phase.The washout period will be one week for psychostimulants and three weeks for non-stimulants.
Arm/Group Title Overall Study: Lisdexamfetamine Treatment
Hide Arm/Group Description The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
Period Title: Overall Study
Started 40
Completed 33
Not Completed 7
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             1
Arm/Group Title LDX Treatment
Hide Arm/Group Description Prospective participants will be evaluated for ADHD and study inclusion/exclusion criteria. Eligible participants will begin open-label lisdexamfetamine dimesylate for 12 weeks. Those who were able to complete all 12 weeks of the treatment were evaluated for data purposes.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
Eligibility was determined by meeting all inclusion criteria and not meeting any of the exclusion criteria. Of the 40 who initially enrolled, 33 completed the full treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
36.4  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
12
  36.4%
Male
21
  63.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Caucasian 21
Black or African-American 5
Hispanic 2
Asian 3
Other/Mixed Ethnicity 2
1.Primary Outcome
Title Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.9  (2.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method GEE regression model
Comments Generalized Estimating Equation (GEE)
2.Secondary Outcome
Title Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group 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.

LDX Treatment: 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.

Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
In Clinic 27.99  (4.17)
Evening 26.9  (5.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method GEE regression model
Comments Generalized Estimating Equation (GEE)
3.Secondary Outcome
Title Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
In Clinic 1.31  (3.70)
Evening -3.34  (3.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .569
Comments [Not Specified]
Method GEE regression model
Comments Generalized Estimating Equation (GEE)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments The following p-value is for AMSES In-Clinic, a subset of the overall AMSES
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .827
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments The following p-value is for AMSES, Evening, a subset of the AMSES
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .569
Comments [Not Specified]
Method Generalized Estimating Equation
Comments [Not Specified]
4.Secondary Outcome
Title Correlation Between AMRS (In Clinic) and ADHD-RS
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Pearson's correlation coefficient
.66
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method GEE regression model
Comments Generalized Estimating Equation (GEE)
5.Secondary Outcome
Title Change in Correlation Between AMRS and TASS
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Pearson's correlation coefficient
In Clinic .96
Evening .96
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method GEE regression model
Comments [Not Specified]
6.Secondary Outcome
Title Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Pearson's correlation coefficient
.83
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method GEE regression model
Comments Generalized Estimating Equation (GEE)
7.Secondary Outcome
Title Psychometric Validation of AMRS
Hide Description To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.
Time Frame Weeks 0-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Cronbach's alpha coefficients
In Clinic .99
Evening .97
8.Secondary Outcome
Title Psychometric Validation of AMSES
Hide Description To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.
Time Frame Weeks 0-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Cronbach's alpha coefficients
In Clinic .92
Evening .87
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LDX Treatment
Hide Arm/Group Description The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
All-Cause Mortality
LDX Treatment
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
LDX Treatment
Affected / at Risk (%) # Events
Total   0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDX Treatment
Affected / at Risk (%) # Events
Total   33/40 (82.50%)    
Gastrointestinal disorders   
Loss of Appetite   21/40 (52.50%)  21
General disorders   
Insomnia   32/40 (80.00%)  34
Dry Mouth   17/40 (42.50%)  17
Vascular disorders   
Headache   21/40 (52.50%)  22
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lenard Adler
Organization: NYU School of Medicine
Phone: (212) 263-3580
EMail: lenard.adler@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01070394    
Other Study ID Numbers: 10-00510
First Submitted: February 16, 2010
First Posted: February 18, 2010
Results First Submitted: April 11, 2013
Results First Posted: November 25, 2016
Last Update Posted: April 3, 2018