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SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00985725
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : April 6, 2012
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: SPD489 (Lisdexamfetamine dimesylate)
Drug: Matching placebo
Enrollment 143
Recruitment Details  
Pre-assignment Details Subjects clinically stable on an anti-depressant were randomized (1:1) to LDX or placebo augmentation for 9 weeks. Double-blind LDX or placebo was administered orally as adjunctive therapy (20 to 70 mg per day, titrated over the initial 6 weeks), with the optimal individual dose being continued during a 3-week dose maintenance period.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks. Administered orally once-daily for 9 weeks.
Period Title: Overall Study
Started 71 72
Completed 60 59
Not Completed 11 13
Reason Not Completed
Adverse Event             4             1
Protocol Violation             1             3
Withdrawal by Subject             4             4
Lost to Follow-up             1             1
Lack of Efficacy             0             1
Non-compliance             1             2
Out-of-window visits             0             1
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo Total
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks. Administered orally once-daily for 9 weeks. Total of all reporting groups
Overall Number of Baseline Participants 71 72 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 72 participants 143 participants
41.9  (9.79) 39.5  (10.59) 40.7  (10.23)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 72 participants 143 participants
18 to 39 years 28 34 62
40 to 55 years 43 38 81
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 72 participants 143 participants
Female
51
  71.8%
48
  66.7%
99
  69.2%
Male
20
  28.2%
24
  33.3%
44
  30.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants 72 participants 143 participants
71 72 143
1.Primary Outcome
Title Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)
Hide Description BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Time Frame Baseline and week 9
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of randomized investigational product and had at least 1 primary efficacy assessment after baseline.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 71 72
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
-21.2  (1.67) -13.2  (1.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.0
Confidence Interval (2-Sided) 95%
-12.7 to -3.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)
Hide Description MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time Frame Baseline and week 9
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 71 72
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-5.0  (0.66) -3.1  (0.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0465
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-3.7 to 0.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in BRIEF-A T-scores at Week 9, LOCF
Hide Description BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Time Frame Baseline and week 9
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 71 72
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
Behavioral recognition index -17.4  (1.51) -12.3  (1.50)
Inhibit subscale -13.5  (1.26) -9.3  (1.25)
Shift subscale -16.2  (1.51) -10.6  (1.50)
Emotional control subscale -13.8  (1.48) -10.1  (1.47)
Self-monitor subscale -13.8  (1.36) -10.7  (1.35)
Metacognition index -21.1  (1.67) -12.2  (1.66)
Initiate subscale -19.4  (1.57) -10.8  (1.56)
Working memory subscale -20.1  (1.65) -11.0  (1.64)
Plan/Organize subscale -18.7  (1.58) -11.3  (1.57)
Task monitor subscale -16.8  (1.63) -11.9  (1.62)
Organization of materials subscale -15.2  (1.49) -8.2  (1.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Behavioral recognition index
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0181
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-9.4 to -0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Inhibit subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0204
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-7.7 to -0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Shift subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0090
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.6
Confidence Interval (2-Sided) 95%
-9.8 to -1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Emotional control subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0793
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-7.9 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Self-monitor subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-7.0 to 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Metacognition index
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.0
Confidence Interval (2-Sided) 95%
-13.7 to -4.3
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Initiate subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.6
Confidence Interval (2-Sided) 95%
-12.9 to -4.2
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Working memory subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.1
Confidence Interval (2-Sided) 95%
-13.7 to -4.5
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Plan/Organize subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.5
Confidence Interval (2-Sided) 95%
-11.9 to -3.1
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Task monitor subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0357
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.9
Confidence Interval (2-Sided) 95%
-9.4 to -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments Organization of materials subscale
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.0
Confidence Interval (2-Sided) 95%
-11.1 to -2.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint
Hide Description This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity. Higher scores are better.
Time Frame Baseline and up to 9 weeks/Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 71 72
Mean (Standard Deviation)
Unit of Measure: Response scores
Complex information speed processing index 8.7  (10.13) 3.7  (9.02)
Executive function index 11.0  (14.80) 6.0  (14.43)
Neurocognitive index 11.5  (17.14) 2.5  (13.74)
5.Secondary Outcome
Title Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Hide Description CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 71 72
Measure Type: Number
Unit of Measure: percentage of participants
Normal, not at all ill 0.0 2.8
Borderline mentally ill 7.0 8.3
Mildly ill 42.3 36.1
Moderately ill 45.1 48.6
Markedly ill 4.2 4.2
Severely ill 1.4 0.0
Among the most extremely ill 0.0 0.0
6.Secondary Outcome
Title Percent of Participants With CGI-S at up to 9 Weeks/Endpoint
Hide Description CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame Up to 9 weeks/Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 69 69
Measure Type: Number
Unit of Measure: percentage of participants
Normal, not at all ill 21.7 15.9
Borderline mentally ill 40.6 23.2
Mildly ill 20.3 24.6
Moderately ill 14.5 34.8
Markedly ill 2.9 1.4
Severely ill 0.0 0.0
Among the most extremely ill 0.0 0.0
7.Secondary Outcome
Title Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF
Hide Description Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 71 72
Measure Type: Number
Unit of Measure: percentage of participants
60.6 38.9
8.Secondary Outcome
Title Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint
Hide Description The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity.
Time Frame Baseline and up to 9 weeks/Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 46 43
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-20.4  (2.24) -15.9  (2.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1731
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-10.9 to 2.0
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF
Hide Description This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.
Time Frame Baseline and week 9
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set (SAS) defined as all randomized subjects who took at least 1 dose of investigational product and for whom at least 1 follow-up safety assessment was completed. Only the males from the SAS population were used and not all of them completed this outcome assessment.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.5  (4.61) 2.4  (5.34)
10.Secondary Outcome
Title Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF
Hide Description This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.
Time Frame Baseline and week 9
Hide Outcome Measure Data
Hide Analysis Population Description
Only the females from the SAS population were used and not all of them completed this outcome assessment.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 48 46
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.7  (8.47) 1.6  (5.60)
11.Secondary Outcome
Title Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9
Hide Description The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health).
Time Frame Baseline and week 9
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 66 66
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Aggregate physical -0.10  (0.461) -0.23  (0.473)
Aggregate mental 0.69  (0.987) 0.63  (0.807)
12.Secondary Outcome
Title Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint
Hide Description The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction.
Time Frame Baseline and up to 9 weeks/Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 68 69
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Physical health activities 17.9  (20.03) 8.2  (16.82)
Overall life satisfaction 12.1  (25.37) 9.1  (22.27)
13.Secondary Outcome
Title Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11
Hide Description ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-9.4  (14.43) -5.9  (10.86)
14.Secondary Outcome
Title Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF
Hide Description The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety.
Time Frame Baseline and week 9
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 71 72
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-4.4  (5.81) -3.8  (5.43)
15.Secondary Outcome
Title Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9
Hide Description The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies.
Time Frame Baseline and week 9
Hide Outcome Measure Data
Hide Analysis Population Description
SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
Administered orally once-daily for 9 weeks.
Overall Number of Participants Analyzed 63 59
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.1  (0.40) 0.0  (0.13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Placebo
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks. Administered orally once-daily for 9 weeks.
All-Cause Mortality
Lisdexamfetamine Dimesylate (LDX) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lisdexamfetamine Dimesylate (LDX) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/71 (2.82%)   4/72 (5.56%) 
Infections and infestations     
Gastroenteritis  0/71 (0.00%)  1/72 (1.39%) 
Salmonellosis  0/71 (0.00%)  1/72 (1.39%) 
Pelvic inflammatory disease  0/71 (0.00%)  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis  0/71 (0.00%)  1/72 (1.39%) 
Nervous system disorders     
Loss of consciousness  1/71 (1.41%)  0/72 (0.00%) 
Psychiatric disorders     
Suicidal ideation  1/71 (1.41%)  0/72 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Lisdexamfetamine Dimesylate (LDX) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   56/71 (78.87%)   53/72 (73.61%) 
Ear and labyrinth disorders     
Hyperacusis  2/71 (2.82%)  0/72 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1/71 (1.41%)  2/72 (2.78%) 
Constipation  2/71 (2.82%)  0/72 (0.00%) 
Diarrhea  2/71 (2.82%)  4/72 (5.56%) 
Dry mouth  11/71 (15.49%)  6/72 (8.33%) 
Gastroesophageal reflux disease  0/71 (0.00%)  3/72 (4.17%) 
Nausea  5/71 (7.04%)  4/72 (5.56%) 
Vomiting  0/71 (0.00%)  2/72 (2.78%) 
General disorders     
Fatigue  4/71 (5.63%)  4/72 (5.56%) 
Feeling jittery  2/71 (2.82%)  1/72 (1.39%) 
Irritability  9/71 (12.68%)  5/72 (6.94%) 
Infections and infestations     
Nasopharyngitis  2/71 (2.82%)  2/72 (2.78%) 
Sinusitis  1/71 (1.41%)  4/72 (5.56%) 
Upper respiratory tract infection  6/71 (8.45%)  4/72 (5.56%) 
Urinary tract infection  7/71 (9.86%)  3/72 (4.17%) 
Viral infection  2/71 (2.82%)  0/72 (0.00%) 
Investigations     
Blood pressure increased  1/71 (1.41%)  2/72 (2.78%) 
Heart rate increased  3/71 (4.23%)  0/72 (0.00%) 
Weight decreased  2/71 (2.82%)  0/72 (0.00%) 
Decreased appetite  16/71 (22.54%)  3/72 (4.17%) 
Metabolism and nutrition disorders     
Anorexia  2/71 (2.82%)  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders     
Back pain  3/71 (4.23%)  1/72 (1.39%) 
Nervous system disorders     
Dizziness  2/71 (2.82%)  3/72 (4.17%) 
Headache  16/71 (22.54%)  11/72 (15.28%) 
Memory impairment  2/71 (2.82%)  0/72 (0.00%) 
Somnolence  4/71 (5.63%)  2/72 (2.78%) 
Tremor  2/71 (2.82%)  0/72 (0.00%) 
Psychiatric disorders     
Abnormal dreams  2/71 (2.82%)  1/72 (1.39%) 
Agitation  2/71 (2.82%)  1/72 (1.39%) 
Anxiety  6/71 (8.45%)  4/72 (5.56%) 
Insomnia  10/71 (14.08%)  2/72 (2.78%) 
Nervousness  2/71 (2.82%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Sinus congestion  0/71 (0.00%)  2/72 (2.78%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  4/71 (5.63%)  0/72 (0.00%) 
Rash  3/71 (4.23%)  1/72 (1.39%) 
Uticaria  2/71 (2.82%)  0/72 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire Pharmaceutical
Phone: 1 866-842-5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00985725     History of Changes
Other Study ID Numbers: SPD489-205
First Submitted: September 25, 2009
First Posted: September 28, 2009
Results First Submitted: February 7, 2012
Results First Posted: April 6, 2012
Last Update Posted: March 23, 2015