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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003019-47 | EudraCT Number |
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SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD489 + Antidepressant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate) + Antidepressant | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 5 up to Week 52/Early Termination(ET) |
| 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]). | Baseline, Week 52/ET |
| 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]). | Baseline, Week 52/ET |
| 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]). | Baseline, Week 52/ET |
| Measure | Description | Time Frame |
|---|---|---|
| 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]). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Research Group | Birmingham | Alabama | 35216 | United States | ||
| ResearchOne, Inc. |
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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]).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Baseline, Week 52/ET |
| 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. | Week 52/ET |
| 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. | Week 52/ET |
| 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 | Week 52/ET |
| 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 | Week 52/ET |
| 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 | Week 52/ET |
| 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 | Week 52/ET |
| 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 | Week 52/ET |
| 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 | Week 52/ET |
| 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. | Week 52/ET |
| 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. | Week 52/ET |
| 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]). | Baseline, Week 52/ET |
| 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. | Week 53 |
| 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. | Week 52/ET |
| 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. | Week 52/ET |
| 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. | Week 52/ET |
| 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. | Week 52/ET |
| 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. | Week 52/ET |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Arkansas Psychiatric Clinical Research Trials, P.A. | Little Rock | Arkansas | 72223 | United States |
| South Coast Clinical Trials, Inc. | Anaheim | California | 92804 | United States |
| American Neuropsychiatric Research, Inc. | Carson | California | 90746 | United States |
| Catalina Research Institute, LLC | Chino | California | 91710 | United States |
| Shanti Clinical Trials | Colton | California | 92324 | United States |
| ATP Clinical Research | Costa Mesa | California | 92626 | United States |
| Clinical Innovation, Inc. | Costa Mesa | California | 92626 | United States |
| Diligent Clinical Trials | Downey | California | 90241 | United States |
| Synergy Clinical Research Center of Escondido | Escondido | California | 92025 | United States |
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | United States |
| UC, Irvine Child Development Center | Irvine | California | 92612 | United States |
| Irvine Center For Clinical Research | Irvine | California | 92618 | United States |
| Omega Clinical Trials, LLC | La Habra | California | 90631 | United States |
| Semel Institute for Neuroscience & Human Behavior at UCLA | Los Angeles | California | 90024 | United States |
| Pacific Research Partners | Oakland | California | 94612 | United States |
| North County Clinical Research | Oceanside | California | 92066 | United States |
| Pasadena Research Institute, LLC | Pasadena | California | 91106 | United States |
| Anderson Clinical Research | Redlands | California | 92374 | United States |
| BreakThrough Clinical Trials, LLC | San Bernardino | California | 92408 | United States |
| Affiliated Research Institute | San Diego | California | 92108 | United States |
| PCSD - Feighner Research | San Diego | California | 92108 | United States |
| Clinical Innovations, Inc. | San Diego | California | 92121 | United States |
| Sharp Mesa Vista Hospital | San Diego | California | 92123' | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | United States |
| Neuropsychiatric Center of Orange County | Santa Ana | California | 92701 | United States |
| Caliifornia Neuroscience Research Medical Group | Sherman Oaks | California | 91403 | United States |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | United States |
| Western Affiliated Research Institute | Denver | Colorado | 80209 | United States |
| Connecticut Clinical Research | Cromwell | Connecticut | 06416 | United States |
| Geriatric and Adult Psychiatry, LLC | Hamden | Connecticut | 06518 | United States |
| Institute of Living - Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34201 | United States |
| CNS Clinical Research Group | Coral Springs | Florida | 33067 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Emerald Coast Mood & Memory, PA | Fort Walton Beach | Florida | 32547 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | United States |
| Amit Vijapura MD | Jacksonville | Florida | 32256 | United States |
| Psychiatric Associates | Lake City | Florida | 32025 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| Fidelity Clinical Research Inc | North Miami | Florida | 33161 | United States |
| Scientific Clinical Research Inc. | North Miami | Florida | 33161 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Ali A. Kashfi, MD, PA | Orlando | Florida | 32889 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Comprehensive Clinical Development, Inc. | St. Petersburg | Florida | 33716 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | United States |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | United States |
| Kolin Research Group | Winter Park | Florida | 32789 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Atlanta Institute of Medicine & Research | Atlanta | Georgia | 30328 | United States |
| Carman Research | Smyrna | Georgia | 30080 | United States |
| Institute for Behavioral Medicine, LLC | Smyrna | Georgia | 30080 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| American Medical Research, Inc. | Oakbrook Terrace | Illinois | 60523 | United States |
| Psyichiatric Medicine Associates, LLC | Skokie | Illinois | 60076 | United States |
| Sleep and Behavior Medicine Institute | Vernon Hills | Illinois | 60061 | United States |
| Davis Clinic | Indianapolis | Indiana | 46250 | United States |
| Pedia Research, LLC | Newburgh | Indiana | 47630 | United States |
| Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | 46383 | United States |
| Clinical Trials Technology, Inc. | Prairie Village | Kansas | 66206 | United States |
| Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| MCM Clinical Research LLC | Florence | Kentucky | 41042 | United States |
| Pedia Research, LLC | Owensboro | Kentucky | 42301 | United States |
| Louisiana Clinical Research LLC | Shreveport | Louisiana | 71101 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| Potomac Grove Clinical Research Center | Gaithersburg | Maryland | 20877 | United States |
| Office of Marc Hertzman, MD | Rockville | Maryland | 20852 | United States |
| Adams Clinical Trials, LLC | Watertown | Massachusetts | 02472 | United States |
| Comprehensive Psyichatric Associates | Gladstone | Missouri | 64118 | United States |
| The Center for Pharmaceutical Research PC | Kansas City | Missouri | 64114 | United States |
| Private Practice - Howard J. Ilivicky | O'Fallon | Missouri | 63368 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63301 | United States |
| Mid-America Clinical Research | St Louis | Missouri | 63109 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Premier Psychiatric Research Institute | Lincoln | Nebraska | 68526 | United States |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | United States |
| Center For Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| CRI Worldwide, LLC | Willingboro | New Jersey | 08046 | United States |
| Albuquerque Neuroscience Inc. | Albuquerque | New Mexico | 87109 | United States |
| Brooklyn Medical Institutes | Brooklyn | New York | 11214 | United States |
| Comprehensive Clinical Development, Inc. | Fresh Meadows | New York | 11366 | United States |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | United States |
| Clinilabs, Inc. | New York | New York | 10019 | United States |
| Medical & Behavioral Health Research, PC | New York | New York | 10023 | United States |
| Fieve Clinical Research | New York | New York | 10075 | United States |
| Mount Sinai School of Medicine | New York | New York | 11029 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Sleep Medicine Centers of Western New York | West Seneca | New York | 14224 | United States |
| Triangle Neuropsyhiatry | Durham | North Carolina | 27707 | United States |
| Clinical Trials of America | Hickory | North Carolina | 28601 | United States |
| Dr. Richard Weisler | Raleigh | North Carolina | 27609 | United States |
| Northcoast Clinical Trials | Beachwood | Ohio | 44122 | United States |
| Community Research, Inc. | Cincinnati | Ohio | 45227 | United States |
| Ohio State University Department of Psychiatry | Columbus | Ohio | 43210 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Lindner Center for Hope | Mason | Ohio | 45040 | United States |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Neurology & Neuroscience Center of Ohio | Toledo | Ohio | 43623 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | United States |
| SP Research, PPC dba Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | United States |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Paramount Clinical Research | Bridgeville | Pennsylvania | 15017 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Belmont Center for Comprehensive Treatment | Philadelphia | Pennsylvania | 19131 | United States |
| CRI Worldwide LLC | Philadelphia | Pennsylvania | 19139 | United States |
| UPMC Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| University Services | West Chester | Pennsylvania | 19380 | United States |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| Medical University of South Carolina, Anxiety Disorders Program | North Charleston | South Carolina | 29406 | United States |
| Psychiatric Consultants, PC | Franklin | Tennessee | 37067 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| FutureSearch Clinical Trials, LP | Austin | Texas | 78731 | United States |
| KRK Medical Research | Dallas | Texas | 75230 | United States |
| Future Search Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Pillar Clinical Research, LLC | Dallas | Texas | 75243 | United States |
| Bay Area Clinical Services | Friendswood | Texas | 77546 | United States |
| Houston Clinical Trials, LLC | Houston | Texas | 77098 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Wharton Research Center, Inc. | Wharton | Texas | 77488 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Ericksen Research and Development | Clinton | Utah | 84015 | United States |
| Alliance Research Group | Richmond | Virginia | 23236 | United States |
| Summit Research Network (Seattle) LLC | Seattle | Washington | 98125 | United States |
| Dean Foundation for Health, Research, and Education | Middleton | Wisconsin | 53562 | United States |
| Independent Physician Consultants (dba IPC Research) | Waukesha | Wisconsin | 53188 | United States |
| Dr. Alexander McIntyre Inc | Penticton | British Columbia | V2A 4M4 | Canada |
| Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc. | Vancouver | British Columbia | V6Z 2L4 | Canada |
| Chatham-Kent Clinical Trials Research Centre | Chatham | Ontario | N7M 5L9 | Canada |
| Anxiety and Mood Disorder Center | Mississauga | Ontario | L5M 4N4 | Canada |
| Dr. Sunny Johnson Medical Corporation, Medican Research Associates | Mississauga | Ontario | L5M 4N4 | Canada |
| A. K. Karan Holdings, Ltd. | Oakville | Ontario | L6J 0B2 | Canada |
| International Sleep Clinic, West Parry Sound Health Centre | Parry Sound | Ontario | P2A 3A4 | Canada |
| START Clinic for Mood and Anxiety Disorders | Toronto | Ontario | M4W2N4 | Canada |
| Sleep & Alertness Clinic | Toronto | Ontario | M6J 3S3 | Canada |
| Manna Research | Toronto | Ontario | M9W 4L6 | Canada |
| Recherches Neuro-Hippocampe | Gatineau | Quebec | J9A 1K7 | Canada |
| l'Hopital Louis H. Lafontaine | Montreal | Quebec | H1N 3M5 | Canada |
| Kells Medical Research Group Inc. | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Q & T Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 4J6 | Canada |
| Especialidades Medicas L y S | Las Condes | Santiagio | 7560356 | Chile |
| Centro de Estudios Clinicos (CEC) | Providencia | Santiago Metropolitan | 7510186 | Chile |
| Biomedica Research Group | Providencia | Santiego | 7500710 | Chile |
| Psicomed Estudio Medicos | Antofagasta | 1270244 | Chile |
| Psychiatrie Ricany | Říčany | Praha Vychod | 251 01 | Czechia |
| Saint Anne s.r.o., Psychiatricka ambulance | Brno | 602 00 | Czechia |
| Psychiatricka ambulance | Brno | 615 00 | Czechia |
| Medicana s.r.o. | Hořovice | 268 01 | Czechia |
| Supervize s.r.o. | Kutná Hora | 284 01 | Czechia |
| Bialbi s.r.o. | Litoměřice | 41201 | Czechia |
| Clintrial s.r.o. | Prague | 120 00 | Czechia |
| Psychiatry Trial, s.r.o | Prague | 15800 | Czechia |
| Medical Services Prague s.r.o. | Prague | 160 00 | Czechia |
| Marienthal Psychiatry & Psychology Center of Mustamae | Tallinn | 10617 | Estonia |
| North Estonia Medical Centre Foundation | Tallinn | Estonia |
| Jaanson & Laane Ou | Tartu | 50406 | Estonia |
| Tartu University Hospital | Tartu | 50417 | Estonia |
| ARTES Psykiatrinen Palvelukeskus Oy | Helsinki | 00100 | Finland |
| Satucon Oy / Privater | Kuopio | 70100 | Finland |
| Puutonin Psykiatripalvelu | Turku | 20100 | Finland |
| Facharzt fur Neurologie und Psychiatrie | Berlin | 10245 | Germany |
| Emovis GmbH | Berlin | 10629 | Germany |
| Complete Facharzt fur Neurologie und Psychiatrie | Berlin | 13156 | Germany |
| Private Practice Drs. Bitter/Schumann | Bochum | 44805 | Germany |
| ZSL Zentrum fuer medizinische Studien in Leipzig | Leipzig | 04157 | Germany |
| Complete Karlstr | München | 80333 | Germany |
| Studienzentrum Klinikum Nuernberg | Nuremberg | 90419 | Germany |
| Somni bene GmbH | Schwerin | 19053 | Germany |
| Gemeinschaftspraxis fur Neurologie und Psychiatrie | Westerstede | 26655 | Germany |
| Medizinisches Studienzentrum Wuerzburg | Würzburg | 97070 | Germany |
| Semmelweis Egyetem Pszichiatrial es Pszichoterapias Klinkia | Budapest | Hungary |
| Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum | Debrecen | Hungary |
| B&B Investigaciones Medicas, SC | Sinaloa | Mazatian | 82126 | Mexico |
| CRI Centro Regiomontano de Investigacion Clinica S.C | Nuevo León | Monterrey | 64710 | Mexico |
| Prywatne Gabinety Lekarskie "Promedicus" Anna Agnieszka Tomczak | Bialystok | 15-879 | Poland |
| Zespol Opleki Zdrowotnej w Chelmole | Chełmno | 86-200 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o. o. | Gdansk | 80-546 | Poland |
| Centrum Badan Klinicznych Pl-House | Gdansk | 80-546 | Poland |
| Klinika Chorob Psychicznych i Zaburzen Nerwicowych Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Klinika Chorob Psychicznych i Zaburzen Nerwicowych | Gdansk | Poland |
| Centrum Psychiatrii i Psychoterapi | Gorlice | 38-300 | Poland |
| NZOZ Syntonia | Kielce | 25-317 | Poland |
| Samodzieiny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie | Żuromin | 09-300 | Poland |
| Dharma Institute and Research Center | San Juan | 00907 | Puerto Rico |
| INSPIRA Clinical Research | San Juan | 00918 | Puerto Rico |
| Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I | Bucharest | 041915' | Romania |
| Lorentina 2102 SRL | Targoviste | 130081 | Romania |
| Spitalui Clinic Judetean Mures | Târgu Mureş | 540096 | Romania |
| Cape Trial Centre | Bellville | Cape Town | 7530 | South Africa |
| Somerset West Clinical Research Unit | Somerset West | Western Cape | South Africa |
| Flexivest Fourteen Research Centre | Cape Town | South Africa |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Fundacion de Alcorcon | Madrid | 28922 | Spain |
| Centro de Salud Mental II la Corredoria | Oviedo | 33011 | Spain |
| Centro de Salud Alamedilla Unidad de Salud Mental | Salamanca | 37003 | Spain |
| Complejo hospitalario de Zamora | Zamora | 49021 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Number | participants | Week 5 up to Week 52/Early Termination(ET) |
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| 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]). | Safety Analysis Set. Here n = participants evaluable at specified time-points. | Posted | Mean | Standard Deviation | millimeter of mercury(mmHg) | Baseline, Week 52/ET |
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| 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]). | Safety Analysis Set. Here n = participants evaluable at specified time-points. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 52/ET |
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| 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]). | Safety Analysis Set. Here n = participants evaluable at specified time-points. | Posted | Mean | Standard Deviation | beats per minute(bpm) | Baseline, Week 52/ET |
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| 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]). | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Number | participants | Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 52/ET |
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| 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 | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Number | participants | Week 52/ET |
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| 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 | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Number | participants | Week 52/ET |
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| 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 | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Number | participants | Week 52/ET |
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| 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 | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Number | participants | Week 52/ET |
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| 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 | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Number | participants | Week 52/ET |
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| 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 | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure | Posted | Mean | Standard Deviation | units on a scale | Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories | Posted | Mean | Standard Deviation | units on a scale | Week 52/ET |
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| 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]). | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 53 |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure | Posted | Number | participants | Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories. | Posted | Mean | Standard Deviation | days | Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories | Posted | Mean | Standard Deviation | events | Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours | Week 52/ET |
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| 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. | FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories | Posted | Mean | Standard Deviation | units on scale | Week 52/ET |
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Up to Week 53
Treatment-Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or deteriorated on or after the date of the first dose of investigational product and no later than 3 days after the last dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 33 | 1,559 | 921 | 1,559 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Intestinal strangulation | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Non-Cardiac chest pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| Gun shot wound | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
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| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Depressive symptom | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Renal mass | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Feeling jittery | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Bruxism | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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The study was terminated on 11 Feb 2014. SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.
If a multi-centre publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multi-centre Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
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