Major Depressive Disorder
Conditions
Brief summary
This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.
Interventions
DRUGSPD489 (Lisdexamfetamine dimesylate) + Antidepressant
SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.
Exclusion criteria
* Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 5 up to Week 52/Early Termination(ET) | C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. |
| Change From Baseline in Systolic Blood Pressure at Week 52 | Baseline, Week 52/ET | Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
| Change From Baseline in Diastolic Blood Pressure at Week 52 | Baseline, Week 52/ET | Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
| Change From Baseline in Pulse Rate at Week 52 | Baseline, Week 52/ET | Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | Week 52/ET | Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses |
| EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | Week 52/ET | Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses |
| EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | Week 52/ET | Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses |
| EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort | Week 52/ET | Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses |
| EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression | Week 52/ET | Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses |
| EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale | Week 52/ET | EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine |
| Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | Week 52/ET | QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16. |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET | Baseline, Week 52/ET | Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
| Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET | Baseline, Week 52/ET | CSFQ-14 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. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]). |
| Amphetamine Cessation Symptom Assessment (ACSA) Total Score | Week 53 | 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. |
| PRUQ-MDD - Number of Days of Resource Utilization | Week 52/ET | The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported. |
| PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Week 52/ET | The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported. |
| PRUQ-MDD - Number of Hours | Week 52/ET | The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported. |
| PRUQ-MDD - Effect of Depressive Symptoms | Week 52/ET | The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale - 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities. |
| Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | Week 52/ET | The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction. |
| Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I) | Week 52/ET | Participants who did not have Clinical Global Impressions - Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. |
| Short Form-12 Health Survey Version 2 (SF-12V2) | Week 52/ET | SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state. |
| Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Week 52/ET | The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions: 1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is. Number of participants with response is reported. |
Countries
Canada, Chile, Czechia, Estonia, Finland, Germany, Hungary, Mexico, Poland, Puerto Rico, Romania, South Africa, Spain, United States
Participant flow
Recruitment details
Study enrolled eligible adults with major depressive disorder (MDD) who had completed treatment in a short-term antecedent SPD489 (lisdexamfetamine dimesylate) MDD study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Participants by arm
| Arm | Count |
|---|---|
| SPD489 + Antidepressant SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride \[HCl\], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines. | 1,559 |
| Total | 1,559 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 111 |
| Overall Study | Lack of Efficacy | 24 |
| Overall Study | Lost to Follow-up | 89 |
| Overall Study | Met blood pressure or pulse withdrawal | 63 |
| Overall Study | Other | 826 |
| Overall Study | Protocol Violation | 49 |
| Overall Study | Withdrawal by Subject | 108 |
Baseline characteristics
| Characteristic | SPD489 + Antidepressant |
|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 11.89 |
| Age, Customized 18-55 Years | 1333 Participants |
| Age, Customized 56-65 Years | 226 Participants |
| Region of Enrollment Argentina | 27 Participants |
| Region of Enrollment Australia | 13 Participants |
| Region of Enrollment Canada | 36 Participants |
| Region of Enrollment Chile | 33 Participants |
| Region of Enrollment Croatia | 5 Participants |
| Region of Enrollment Czech Republic | 83 Participants |
| Region of Enrollment Estonia | 24 Participants |
| Region of Enrollment Finland | 8 Participants |
| Region of Enrollment Germany | 69 Participants |
| Region of Enrollment Hungary | 4 Participants |
| Region of Enrollment Mexico | 27 Participants |
| Region of Enrollment Poland | 20 Participants |
| Region of Enrollment Romania | 8 Participants |
| Region of Enrollment South Africa | 5 Participants |
| Region of Enrollment Spain | 6 Participants |
| Region of Enrollment United Kingdom | 1 Participants |
| Region of Enrollment United States | 1190 Participants |
| Sex: Female, Male Female | 1056 Participants |
| Sex: Female, Male Male | 503 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 921 / 1,559 |
| serious Total, serious adverse events | 33 / 1,559 |
Outcome results
Primary
Change From Baseline in Diastolic Blood Pressure at Week 52
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Time frame: Baseline, Week 52/ET
Population: Safety Analysis Set. Here n = participants evaluable at specified time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | Change From Baseline in Diastolic Blood Pressure at Week 52 | Baseline (n = 1559) | 75.4 mmHg | Standard Deviation 8.15 |
| SPD489 + Antidepressant | Change From Baseline in Diastolic Blood Pressure at Week 52 | Change at Week 52/ET (n = 1558) | 1.2 mmHg | Standard Deviation 7.94 |
Primary
Change From Baseline in Pulse Rate at Week 52
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Time frame: Baseline, Week 52/ET
Population: Safety Analysis Set. Here n = participants evaluable at specified time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | Change From Baseline in Pulse Rate at Week 52 | Baseline (n = 1559) | 72.7 beats per minute(bpm) | Standard Deviation 9.9 |
| SPD489 + Antidepressant | Change From Baseline in Pulse Rate at Week 52 | Change at Week 52/ET (n = 1558) | 5.2 beats per minute(bpm) | Standard Deviation 10.58 |
Primary
Change From Baseline in Systolic Blood Pressure at Week 52
Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Time frame: Baseline, Week 52/ET
Population: Safety Analysis Set. Here n = participants evaluable at specified time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | Change From Baseline in Systolic Blood Pressure at Week 52 | Baseline (n = 1559) | 117.6 millimeter of mercury(mmHg) | Standard Deviation 11.13 |
| SPD489 + Antidepressant | Change From Baseline in Systolic Blood Pressure at Week 52 | Change at Week 52/ET (n = 1558) | 2.4 millimeter of mercury(mmHg) | Standard Deviation 10.37 |
Primary
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Time frame: Week 5 up to Week 52/Early Termination(ET)
Population: Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 + Antidepressant | Columbia-Suicide Severity Rating Scale (C-SSRS) | Positive Suicidal Ideation | 68 participants |
| SPD489 + Antidepressant | Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Attempt | 4 participants |
Secondary
Amphetamine Cessation Symptom Assessment (ACSA) Total Score
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: Week 53
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 + Antidepressant | Amphetamine Cessation Symptom Assessment (ACSA) Total Score | 14.3 units on a scale | Standard Deviation 10.59 |
Secondary
Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
CSFQ-14 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. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Time frame: Baseline, Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET | Male: Baseline (n=167) | 46.6 units on a scale | Standard Deviation 9.17 |
| SPD489 + Antidepressant | Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET | Male: Change at Week 52/ET (n=164) | 1.7 units on a scale | Standard Deviation 7.16 |
| SPD489 + Antidepressant | Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET | Female: Baseline (n=341) | 37.2 units on a scale | Standard Deviation 9.65 |
| SPD489 + Antidepressant | Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET | Female: Change at Week 52/ET (n=330) | 2.8 units on a scale | Standard Deviation 8.33 |
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Time frame: Baseline, Week 52/ET
Population: Full Analysis Set (FAS) included all participants in the Safety Analysis Set who had at least 1 clinical experience outcome assessment in the study. Here n = participants evaluable at specified time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET | Baseline (n=1548) | 12.7 units on a scale | Standard Deviation 7.06 |
| SPD489 + Antidepressant | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET | Change at Week 52/ET (n = 1530) | -4.3 units on a scale | Standard Deviation 7.77 |
Secondary
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression | Not anxious or depressed | 461 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression | Slightly anxious or depressed | 687 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression | Moderately anxious or depressed | 289 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression | Severely anxious or depressed | 73 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression | Extremely anxious or depressed | 27 participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | No problems in walking about | 1193 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | Slight problems in walking about | 237 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | Moderate problems in walking about | 82 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | Severe problems in walking about | 24 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility | Unable to walk about | 1 participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort | No pain or discomfort | 715 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort | Slight pain or discomfort | 536 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort | Moderate pain or discomfort | 208 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort | Severe pain or discomfort | 68 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort | Extreme pain or discomfort | 10 participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | No problems washing or dressing myself | 1304 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | Slight problems washing or dressing myself | 174 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | Moderate problems washing or dressing myself | 49 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | Severe problems washing or dressing myself | 9 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care | Unable to wash or dress myself | 1 participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | No problems doing my usual activities | 800 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | Slight problems doing my usual activities | 475 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | Moderate problems doing my usual activities | 197 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | Severe problems doing my usual activities | 55 participants |
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities | Unable to do my usual activities | 10 participants |
Secondary
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale
EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 + Antidepressant | EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale | 75.7 units on a scale | Standard Deviation 18.35 |
Secondary
Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)
Participants who did not have Clinical Global Impressions - Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD489 + Antidepressant | Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I) | 1021 participants |
Secondary
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions: 1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is. Number of participants with response is reported.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Hospitalized in Past Month | 4 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Work for Pay | 337 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason Missing Work Time: Had a Day Off | 24 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason Missing Work Time: Physically Ill | 10 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason Missing Work Time: Upset/Depressed/Nervous | 15 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason Missing Work Time: Other | 36 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Past Week Was Typical: Yes | 249 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Past Week Was Typical: No, Worked More Hours | 43 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Past Week Was Typical: No, Worked Less Hours | 45 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Volunteer Work | 86 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason no Money/VW: Physically Ill | 6 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason no Money/VW: Upset/Depressed/Nervous | 30 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason no Money/VW: Cannot Find Work | 39 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason no Money/VW: Other | 48 participants |
| SPD489 + Antidepressant | Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD) | Reason no Money/VW: Not Applicable | 348 participants |
Secondary
PRUQ-MDD - Effect of Depressive Symptoms
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale - 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | PRUQ-MDD - Effect of Depressive Symptoms | Affected work productivity (n= 335) | 2.1 units on scale | Standard Deviation 2.37 |
| SPD489 + Antidepressant | PRUQ-MDD - Effect of Depressive Symptoms | Affected regular non work daily activities (n=482) | 2.5 units on scale | Standard Deviation 2.43 |
Secondary
PRUQ-MDD - Number of Days of Resource Utilization
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | PRUQ-MDD - Number of Days of Resource Utilization | Number of nights in medical/surgical ward (n=4) | 1.3 days | Standard Deviation 0.5 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Days of Resource Utilization | Number of nights in ICU (n=4) | 0.0 days | Standard Deviation 0 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Days of Resource Utilization | Number of days received home care in past month | 0.0 days | Standard Deviation 0 |
Secondary
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Visit to Family doctor/primary care (n=481) | 0.2 events | Standard Deviation 0.58 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Visit to NPHP(n=480) | 0.1 events | Standard Deviation 0.43 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Visit to PPC(n=481) | 0.1 events | Standard Deviation 0.86 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Test performed: Blood Test (n=480) | 0.2 events | Standard Deviation 2.3 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Test performed: CT Scan (n=480) | 0.0 events | Standard Deviation 0.08 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Test performed: X Ray (n=480) | 0.0 events | Standard Deviation 0.2 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Test performed: Renal function (n=480) | 0.0 events | Standard Deviation 0 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Test performed: Thyroid function (n=480) | 0.0 events | Standard Deviation 0.09 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Test performed: Other test (n=479) | 0.1 events | Standard Deviation 0.49 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed) | Visit to Hospital ER, UCF or AHC (n=482) | 0.0 events | Standard Deviation 0.23 |
Secondary
PRUQ-MDD - Number of Hours
The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | PRUQ-MDD - Number of Hours | Work or usually expect to work (n=337) | 34.0 hours | Standard Deviation 11.85 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Hours | Actual work (n=337) | 31.2 hours | Standard Deviation 15.13 |
| SPD489 + Antidepressant | PRUQ-MDD - Number of Hours | Average volunteer per week (n=86) | 8.6 hours | Standard Deviation 8.94 |
Secondary
Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | Summary Scale (n = 506) | 61.5 units on a scale | Standard Deviation 17.22 |
| SPD489 + Antidepressant | Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | Satisfaction with Medication (n = 478) | 68.6 units on a scale | Standard Deviation 19.66 |
| SPD489 + Antidepressant | Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) | Overall Satisfaction and Contentment (n = 506) | 63.2 units on a scale | Standard Deviation 21.58 |
Secondary
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 + Antidepressant | Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | 6.9 units on a scale | Standard Deviation 4.48 |
Secondary
Short Form-12 Health Survey Version 2 (SF-12V2)
SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.
Time frame: Week 52/ET
Population: FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 + Antidepressant | Short Form-12 Health Survey Version 2 (SF-12V2) | Aggregate Physical | 49.1 units on a scale | Standard Deviation 9.67 |
| SPD489 + Antidepressant | Short Form-12 Health Survey Version 2 (SF-12V2) | Aggregate Mental | 42.7 units on a scale | Standard Deviation 11.55 |