Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder
Brief summary
To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).
Interventions
Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily
DRUGMatching placebo
oral, once daily
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression
Exclusion criteria
* Current co-morbid psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline and week 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Baseline and week 9 | 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. |
| Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint | Baseline and up to 9 weeks/Endpoint | 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. |
| Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Baseline | 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) |
| Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Up to 9 weeks/Endpoint | 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) |
| Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF | Week 9 | 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. |
| Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint | Baseline and up to 9 weeks/Endpoint | 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. |
| Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF) | Baseline and week 9 | 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. |
| Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF | Baseline and week 9 | 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. |
| Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 | Baseline and week 9 | 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). |
| Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint | Baseline and up to 9 weeks/Endpoint | 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. |
| Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11 | Baseline and week 11 | 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. |
| Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF | Baseline and week 9 | 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. |
| Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9 | Baseline and week 9 | 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. |
| Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF | Baseline and week 9 | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks. | 71 |
| Placebo Administered orally once-daily for 9 weeks. | 72 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Non-compliance | 1 | 2 |
| Overall Study | Out-of-window visits | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Lisdexamfetamine Dimesylate (LDX) | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 9.79 | 39.5 years STANDARD_DEVIATION 10.59 | 40.7 years STANDARD_DEVIATION 10.23 |
| Age, Customized 18 to 39 years | 28 Participants | 34 Participants | 62 Participants |
| Age, Customized 40 to 55 years | 43 Participants | 38 Participants | 81 Participants |
| Region of Enrollment United States | 71 Participants | 72 Participants | 143 Participants |
| Sex: Female, Male Female | 51 Participants | 48 Participants | 99 Participants |
| Sex: Female, Male Male | 20 Participants | 24 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 71 | 53 / 72 |
| serious Total, serious adverse events | 2 / 71 | 4 / 72 |
Outcome results
Primary
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)
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | 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) | -21.2 T-scores | Standard Error 1.67 |
| Placebo | 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) | -13.2 T-scores | Standard Error 1.66 |
p-value: 0.000995% CI: [-12.7, -3.3]ANCOVA
Secondary
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11 | -9.4 Scores on a scale | Standard Deviation 14.43 |
| Placebo | Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11 | -5.9 Scores on a scale | Standard Deviation 10.86 |
Secondary
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF
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
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Emotional control subscale | -13.8 T-scores | Standard Error 1.48 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Initiate subscale | -19.4 T-scores | Standard Error 1.57 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Shift subscale | -16.2 T-scores | Standard Error 1.51 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Working memory subscale | -20.1 T-scores | Standard Error 1.65 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Self-monitor subscale | -13.8 T-scores | Standard Error 1.36 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Plan/Organize subscale | -18.7 T-scores | Standard Error 1.58 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Inhibit subscale | -13.5 T-scores | Standard Error 1.26 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Task monitor subscale | -16.8 T-scores | Standard Error 1.63 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Metacognition index | -21.1 T-scores | Standard Error 1.67 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Organization of materials subscale | -15.2 T-scores | Standard Error 1.49 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Behavioral recognition index | -17.4 T-scores | Standard Error 1.51 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Organization of materials subscale | -8.2 T-scores | Standard Error 1.48 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Behavioral recognition index | -12.3 T-scores | Standard Error 1.5 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Inhibit subscale | -9.3 T-scores | Standard Error 1.25 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Shift subscale | -10.6 T-scores | Standard Error 1.5 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Emotional control subscale | -10.1 T-scores | Standard Error 1.47 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Self-monitor subscale | -10.7 T-scores | Standard Error 1.35 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Metacognition index | -12.2 T-scores | Standard Error 1.66 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Initiate subscale | -10.8 T-scores | Standard Error 1.56 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Working memory subscale | -11.0 T-scores | Standard Error 1.64 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Plan/Organize subscale | -11.3 T-scores | Standard Error 1.57 |
| Placebo | Change From Baseline in BRIEF-A T-scores at Week 9, LOCF | Task monitor subscale | -11.9 T-scores | Standard Error 1.62 |
Comparison: Behavioral recognition indexp-value: 0.018195% CI: [-9.4, -0.9]ANCOVA
Comparison: Inhibit subscalep-value: 0.020495% CI: [-7.7, -0.7]ANCOVA
Comparison: Shift subscalep-value: 0.00995% CI: [-9.8, -1.4]ANCOVA
Comparison: Emotional control subscalep-value: 0.079395% CI: [-7.9, 0.4]ANCOVA
Comparison: Self-monitor subscalep-value: 0.101495% CI: [-7, 0.6]ANCOVA
Comparison: Metacognition indexp-value: 0.000295% CI: [-13.7, -4.3]ANCOVA
Comparison: Initiate subscalep-value: 0.000295% CI: [-12.9, -4.2]ANCOVA
Comparison: Working memory subscalep-value: 0.000195% CI: [-13.7, -4.5]ANCOVA
Comparison: Plan/Organize subscalep-value: 0.00195% CI: [-11.9, -3.1]ANCOVA
Comparison: Task monitor subscalep-value: 0.035795% CI: [-9.4, -0.3]ANCOVA
Comparison: Organization of materials subscalep-value: 0.001295% CI: [-11.1, -2.8]ANCOVA
Secondary
Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint
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
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint | Complex information speed processing index | 8.7 Response scores | Standard Deviation 10.13 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint | Executive function index | 11.0 Response scores | Standard Deviation 14.8 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint | Neurocognitive index | 11.5 Response scores | Standard Deviation 17.14 |
| Placebo | Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint | Complex information speed processing index | 3.7 Response scores | Standard Deviation 9.02 |
| Placebo | Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint | Executive function index | 6.0 Response scores | Standard Deviation 14.43 |
| Placebo | Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint | Neurocognitive index | 2.5 Response scores | Standard Deviation 13.74 |
Secondary
Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF | 2.5 Scores on a scale | Standard Deviation 4.61 |
| Placebo | Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF | 2.4 Scores on a scale | Standard Deviation 5.34 |
Secondary
Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF
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
Population: Only the females from the SAS population were used and not all of them completed this outcome assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF | 2.7 Scores on a scale | Standard Deviation 8.47 |
| Placebo | Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF | 1.6 Scores on a scale | Standard Deviation 5.6 |
Secondary
Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint | -20.4 Scores on a scale | Standard Error 2.24 |
| Placebo | Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint | -15.9 Scores on a scale | Standard Error 2.32 |
p-value: 0.173195% CI: [-10.9, 2]ANCOVA
Secondary
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)
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
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF) | -5.0 Scores on a scale | Standard Error 0.66 |
| Placebo | Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF) | -3.1 Scores on a scale | Standard Error 0.66 |
p-value: 0.046595% CI: [-3.7, 0]ANCOVA
Secondary
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint | Physical health activities | 17.9 Scores on a scale | Standard Deviation 20.03 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint | Overall life satisfaction | 12.1 Scores on a scale | Standard Deviation 25.37 |
| Placebo | Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint | Physical health activities | 8.2 Scores on a scale | Standard Deviation 16.82 |
| Placebo | Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint | Overall life satisfaction | 9.1 Scores on a scale | Standard Deviation 22.27 |
Secondary
Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9 | -0.1 Scores on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9 | 0.0 Scores on a scale | Standard Deviation 0.13 |
Secondary
Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 | Aggregate physical | -0.10 Scores on a scale | Standard Deviation 0.461 |
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 | Aggregate mental | 0.69 Scores on a scale | Standard Deviation 0.987 |
| Placebo | Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 | Aggregate physical | -0.23 Scores on a scale | Standard Deviation 0.473 |
| Placebo | Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 | Aggregate mental | 0.63 Scores on a scale | Standard Deviation 0.807 |
Secondary
Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF
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
Population: SAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF | -4.4 Scores on a scale | Standard Deviation 5.81 |
| Placebo | Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF | -3.8 Scores on a scale | Standard Deviation 5.43 |
Secondary
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF
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
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF | 60.6 percentage of participants |
| Placebo | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF | 38.9 percentage of participants |
Secondary
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Severely ill | 0.0 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Normal, not at all ill | 21.7 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Borderline mentally ill | 40.6 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Mildly ill | 20.3 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Moderately ill | 14.5 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Markedly ill | 2.9 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Among the most extremely ill | 0.0 percentage of participants |
| Placebo | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Severely ill | 0.0 percentage of participants |
| Placebo | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Moderately ill | 34.8 percentage of participants |
| Placebo | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Normal, not at all ill | 15.9 percentage of participants |
| Placebo | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Among the most extremely ill | 0.0 percentage of participants |
| Placebo | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Borderline mentally ill | 23.2 percentage of participants |
| Placebo | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Markedly ill | 1.4 percentage of participants |
| Placebo | Percent of Participants With CGI-S at up to 9 Weeks/Endpoint | Mildly ill | 24.6 percentage of participants |
Secondary
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
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
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Mildly ill | 42.3 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Markedly ill | 4.2 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Borderline mentally ill | 7.0 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Severely ill | 1.4 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Moderately ill | 45.1 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Among the most extremely ill | 0.0 percentage of participants |
| Lisdexamfetamine Dimesylate (LDX) | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Normal, not at all ill | 0.0 percentage of participants |
| Placebo | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Among the most extremely ill | 0.0 percentage of participants |
| Placebo | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Normal, not at all ill | 2.8 percentage of participants |
| Placebo | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Borderline mentally ill | 8.3 percentage of participants |
| Placebo | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Mildly ill | 36.1 percentage of participants |
| Placebo | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Moderately ill | 48.6 percentage of participants |
| Placebo | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Markedly ill | 4.2 percentage of participants |
| Placebo | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Severely ill | 0.0 percentage of participants |