{"protocolSection":{"identificationModule":{"nctId":"NCT00905424","orgStudyIdInfo":{"id":"SPD489-203"},"organization":{"fullName":"Takeda","class":"INDUSTRY"},"briefTitle":"Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant","officialTitle":"A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant"},"statusModule":{"statusVerifiedDate":"2021-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-07-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2010-08-04","type":"ACTUAL"},"completionDateStruct":{"date":"2010-08-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-05-18","studyFirstSubmitQcDate":"2009-05-19","studyFirstPostDateStruct":{"date":"2009-05-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-06-15","resultsFirstSubmitQcDate":"2011-06-15","resultsFirstPostDateStruct":{"date":"2011-07-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2021-06-08","lastUpdatePostDateStruct":{"date":"2021-06-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Shire","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores."},"conditionsModule":{"conditions":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":246,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Active","type":"EXPERIMENTAL","description":"Antidepressant + SPD489","interventionNames":["Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate)"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Antidepressant + placebo","interventionNames":["Drug: Antidepressant + placebo"]}],"interventions":[{"type":"DRUG","name":"Antidepressant + SPD489 (lisdexamfetamine dimesylate)","description":"Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks","armGroupLabels":["Active"],"otherNames":["LDX, Vyvanse"]},{"type":"DRUG","name":"Antidepressant + placebo","description":"Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)","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.","timeFrame":"Augmentation Baseline, 6 weeks"}],"secondaryOutcomes":[{"measure":"Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF","description":"The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.","timeFrame":"Augmentation Baseline, 6 weeks"},{"measure":"Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6","description":"Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, 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.","timeFrame":"Augmentation Baseline, 6 weeks"},{"measure":"Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF","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.","timeFrame":"6 weeks"},{"measure":"Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline","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)","timeFrame":"Augmentation baseline"},{"measure":"Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6","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)","timeFrame":"6 weeks"},{"measure":"Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6","description":"BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.","timeFrame":"Augmentation Baseline and 6 weeks"},{"measure":"Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6","description":"MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.","timeFrame":"Augmentation Baseline and 6 weeks"},{"measure":"Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6","description":"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.","timeFrame":"Augmentation Baseline and 6 weeks"},{"measure":"Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF","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.","timeFrame":"Augmentation Baseline and 6 weeks"},{"measure":"Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF","description":"The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.","timeFrame":"Augmentation Baseline and 6 weeks"},{"measure":"Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6","description":"Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, 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.","timeFrame":"Augmentation Baseline and 6 weeks"},{"measure":"Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF","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.","timeFrame":"6 weeks"},{"measure":"Assessment in Remitters of CGI-S at Augmentation Baseline","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)","timeFrame":"Augmentation Baseline"},{"measure":"Assessment in Remitters of CGI-S at Week 6","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)","timeFrame":"6 weeks"},{"measure":"Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6","description":"BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.","timeFrame":"Augmentation baseline and 6 weeks"},{"measure":"Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6","description":"MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.","timeFrame":"Augmentation baseline and 6 weeks"},{"measure":"Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6","description":"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.","timeFrame":"Augmentation baseline and 6 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD\n\nExclusion Criteria:\n\n* History of non-response to multiple antidepressants","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Study Director","affiliation":"Takeda","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pharmacology Research Institute (PRI)","city":"Newport Beach","state":"California","zip":"92660","country":"United States","geoPoint":{"lat":33.61891,"lon":-117.92895}},{"facility":"Affiliated Research Institute","city":"San Diego","state":"California","zip":"92108","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Florida Clinical Research Center, LLC","city":"Bradenton","state":"Florida","zip":"34208","country":"United States","geoPoint":{"lat":27.49893,"lon":-82.57482}},{"facility":"Gulfcoast Clinical Research Center","city":"Fort Myers","state":"Florida","zip":"33912","country":"United States","geoPoint":{"lat":26.62168,"lon":-81.84059}},{"facility":"Clinical Neuroscience Solutions, Inc.","city":"Orlando","state":"Florida","zip":"32809","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Atlanta Institute of Medicine & Research","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Carman Research","city":"Smyrna","state":"Georgia","zip":"30080","country":"United States","geoPoint":{"lat":33.88399,"lon":-84.51438}},{"facility":"Vince & Associates Clinical Research","city":"Overland Park","state":"Kansas","zip":"66212","country":"United States","geoPoint":{"lat":38.98223,"lon":-94.67079}},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","zip":"27705","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}},{"facility":"North Star Medical Research, LLC","city":"Middleburg Heights","state":"Ohio","zip":"44130","country":"United States","geoPoint":{"lat":41.36144,"lon":-81.81291}},{"facility":"IPS Research Company","city":"Oklahoma City","state":"Oklahoma","zip":"73103","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Summit Research Network","city":"Portland","state":"Oregon","zip":"97210","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"FutureSearch Clinical Trials, LP","city":"Austin","state":"Texas","zip":"78756","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","zip":"98007","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}},{"facility":"Summit Research Network (Seattle), LLC","city":"Seattle","state":"Washington","zip":"98104","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}}]},"referencesModule":{"references":[{"pmid":"24021497","type":"RESULT","citation":"Trivedi MH, Cutler AJ, Richards C, Lasser R, Geibel BB, Gao J, Sambunaris A, Patkar AA. A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram. J Clin Psychiatry. 2013 Aug;74(8):802-9. doi: 10.4088/JCP.13m08360."}],"seeAlsoLinks":[{"label":"FDA Recall Information","url":"http://www.fda.gov/opacom/7alerts.html"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"246 subjects entered the antidepressant lead-in phase receiving escitalopram oxalate (antidepressant) 20 mg/day for 8 weeks. After 8 weeks, subjects with residual depressive symptoms (n = 177) were randomly assigned (stratified by remission, either remitters or non-remitters) to receive augmentation therapy (either SPD489 or placebo).","groups":[{"id":"FG000","title":"Antidepressant + SPD489","description":"Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale \\[MADRS\\] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline)."},{"id":"FG001","title":"Antidepressant + Placebo .","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"89"},{"groupId":"FG001","numSubjects":"88"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"79"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"9"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Non-compliance with study medication","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Sponsor decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Positive urine drug screen","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Non-adherence to visit schedule","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Antidepressant + SPD489","description":"Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale \\[MADRS\\] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline)."},{"id":"BG001","title":"Antidepressant + Placebo .","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"173"}]}],"measures":[{"title":"Age, Continuous","description":"177 subjects were randomized. However, 4 withdrew before receiving any randomized augmentation treatment. Therefore, 173 subjects were included in the Randomized Safety Analysis Set defined as all subjects who took at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.4","spread":"9.65"},{"groupId":"BG001","value":"38.6","spread":"10.38"},{"groupId":"BG002","value":"39.0","spread":"9.99"}]}]}]},{"title":"Age, Customized","description":"177 subjects were randomized. However, 4 withdrew before receiving any randomized augmentation treatment. Therefore, 173 subjects were included in the Randomized Safety Analysis Set defined as all subjects who took at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"18-40 years","categories":[{"measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"93"}]}]},{"title":"41-55 years","categories":[{"measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"80"}]}]}]},{"title":"Sex: Female, Male","description":"177 subjects were randomized. However, 4 withdrew before receiving any randomized augmentation treatment. Therefore, 173 subjects were included in the Randomized Safety Analysis Set defined as all subjects who took at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"107"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"66"}]}]}]},{"title":"Region of Enrollment","description":"177 subjects were randomized. However, 4 withdrew before receiving any randomized augmentation treatment. Therefore, 173 subjects were included in the Randomized Safety Analysis Set defined as all subjects who took at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"173"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)","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.","populationDescription":"Primary Efficacy Analysis Set defined as all non-remitters (MADRS total score greater than 10 at augmentation baseline) who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Augmentation Baseline, 6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.1","spread":"0.93"},{"groupId":"OG001","value":"-4.9","spread":"0.94"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0902","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-2.3","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.5","ciUpperLimit":"-0.1"}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF","description":"The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.","populationDescription":"Primary Efficacy Analysis Set","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Augmentation Baseline, 6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.9","spread":"0.64"},{"groupId":"OG001","value":"-4.0","spread":"0.65"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3091","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-0.9","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.4","ciUpperLimit":"0.6"}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6","description":"Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, 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.","populationDescription":"Primary Efficacy Analysis Set","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Augmentation Baseline, 6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.7","spread":"0.73"},{"groupId":"OG001","value":"-1.7","spread":"0.74"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0573","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-2.0","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.7","ciUpperLimit":"-0.3"}]},{"type":"SECONDARY","title":"Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF","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.","populationDescription":"Primary Efficacy Analysis Set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of Participants","timeFrame":"6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"64"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60.0"},{"groupId":"OG001","value":"45.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.2368","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline","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)","populationDescription":"Primary Efficacy Analysis Set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of participants","timeFrame":"Augmentation baseline","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). 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Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"}]}],"classes":[{"title":"Normal, not at all ill","categories":[{"measurements":[{"groupId":"OG000","value":"1.5"},{"groupId":"OG001","value":"1.6"}]}]},{"title":"Borderline mentally ill","categories":[{"measurements":[{"groupId":"OG000","value":"20.0"},{"groupId":"OG001","value":"12.5"}]}]},{"title":"Mildly ill","categories":[{"measurements":[{"groupId":"OG000","value":"40.0"},{"groupId":"OG001","value":"34.4"}]}]},{"title":"Moderately ill","categories":[{"measurements":[{"groupId":"OG000","value":"32.3"},{"groupId":"OG001","value":"48.4"}]}]},{"title":"Markedly ill","categories":[{"measurements":[{"groupId":"OG000","value":"6.2"},{"groupId":"OG001","value":"3.1"}]}]},{"title":"Severely ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Among the most extremely ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6","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)","populationDescription":"Primary Efficacy Analysis Set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of participants","timeFrame":"6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"62"}]}],"classes":[{"title":"Normal, not at all ill","categories":[{"measurements":[{"groupId":"OG000","value":"27.0"},{"groupId":"OG001","value":"14.5"}]}]},{"title":"Borderline mentally ill","categories":[{"measurements":[{"groupId":"OG000","value":"31.7"},{"groupId":"OG001","value":"24.2"}]}]},{"title":"Mildly ill","categories":[{"measurements":[{"groupId":"OG000","value":"30.2"},{"groupId":"OG001","value":"22.6"}]}]},{"title":"Moderately ill","categories":[{"measurements":[{"groupId":"OG000","value":"9.5"},{"groupId":"OG001","value":"29.0"}]}]},{"title":"Markedly ill","categories":[{"measurements":[{"groupId":"OG000","value":"1.6"},{"groupId":"OG001","value":"9.7"}]}]},{"title":"Severely ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Among the most extremely ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6","description":"BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). 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Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"60"}]}],"classes":[{"title":"Global Executive Composite","categories":[{"measurements":[{"groupId":"OG000","value":"-4.7","spread":"1.03"},{"groupId":"OG001","value":"-1.7","spread":"1.04"}]}]},{"title":"Behavioral Regulation Index","categories":[{"measurements":[{"groupId":"OG000","value":"-3.7","spread":"0.97"},{"groupId":"OG001","value":"-1.7","spread":"0.99"}]}]},{"title":"Metacognition Index","categories":[{"measurements":[{"groupId":"OG000","value":"-4.8","spread":"1.04"},{"groupId":"OG001","value":"-1.5","spread":"1.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Global Executive Composite","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0463","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-3.0","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.4","ciUpperLimit":"-0.5"},{"groupIds":["OG000","OG001"],"groupDescription":"Behavioral Regulation Index","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1431","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-2.0","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.3","ciUpperLimit":"0.3"},{"groupIds":["OG000","OG001"],"groupDescription":"Metacognition Index","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0281","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-3.3","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.8","ciUpperLimit":"-0.8"}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6","description":"MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.","populationDescription":"Primary Efficacy Analysis Set","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Augmentation Baseline and 6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.3","spread":"1.25"},{"groupId":"OG001","value":"-2.3","spread":"1.26"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0920","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-3.0","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.0","ciUpperLimit":"-0.1"}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6","description":"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.","populationDescription":"Primary Efficacy Analysis Set","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Augmentation Baseline and 6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Non-remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"62"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.4","spread":"0.45"},{"groupId":"OG001","value":"-1.2","spread":"0.46"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0774","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-1.2","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.2","ciUpperLimit":"-0.1"}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF","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.","populationDescription":"Full Analysis Set (FAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Augmentation Baseline and 6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"1.13"},{"groupId":"OG001","value":"-1.1","spread":"1.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.4726","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"1.2","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.6","ciUpperLimit":"4.0"}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF","description":"The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.","populationDescription":"FAS","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Augmentation Baseline and 6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"0.92"},{"groupId":"OG001","value":"-1.6","spread":"0.96"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.5182","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.9","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.4","ciUpperLimit":"3.1"}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6","description":"Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, 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.","populationDescription":"FAS","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Augmentation Baseline and 6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"0.89"},{"groupId":"OG001","value":"-0.6","spread":"0.91"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.4630","pValueComment":"The test was performed a priori at the significance level of 0.10","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-0.9","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.1","ciUpperLimit":"1.2"}]},{"type":"SECONDARY","title":"Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF","description":"Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). 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Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"65.2"},{"groupId":"OG001","value":"52.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.5230","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Assessment in Remitters of CGI-S at Augmentation Baseline","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)","populationDescription":"FAS","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of participants","timeFrame":"Augmentation Baseline","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). 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Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"21"}]}],"classes":[{"title":"Normal, not at all ill","categories":[{"measurements":[{"groupId":"OG000","value":"26.1"},{"groupId":"OG001","value":"23.8"}]}]},{"title":"Borderline mentally ill","categories":[{"measurements":[{"groupId":"OG000","value":"47.8"},{"groupId":"OG001","value":"71.4"}]}]},{"title":"Mildly ill","categories":[{"measurements":[{"groupId":"OG000","value":"21.7"},{"groupId":"OG001","value":"4.8"}]}]},{"title":"Moderately ill","categories":[{"measurements":[{"groupId":"OG000","value":"4.3"},{"groupId":"OG001","value":"0"}]}]},{"title":"Markedly ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Severely ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Among the most extremely ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Assessment in Remitters of CGI-S at Week 6","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)","populationDescription":"FAS","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of participants","timeFrame":"6 weeks","groups":[{"id":"OG000","title":"Antidepressant + SPD489 (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks."},{"id":"OG001","title":"Antidepressant + Placebo (Remitters)","description":"Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"21"}]}],"classes":[{"title":"Normal, not at all ill","categories":[{"measurements":[{"groupId":"OG000","value":"50.0"},{"groupId":"OG001","value":"61.9"}]}]},{"title":"Borderline mentally ill","categories":[{"measurements":[{"groupId":"OG000","value":"36.4"},{"groupId":"OG001","value":"23.8"}]}]},{"title":"Mildly ill","categories":[{"measurements":[{"groupId":"OG000","value":"13.6"},{"groupId":"OG001","value":"9.5"}]}]},{"title":"Moderately ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4.8"}]}]},{"title":"Markedly ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Severely ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Among the most extremely ill","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6","description":"BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). 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