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This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 5461 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 5461 | Drug | Sublingual tablet, taken daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 56 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sanjeev Pathak, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Birmingham | Alabama | 35226 | United States | ||
| Alkermes Investigational Site |
All subjects received ALKS 5461 during the course of the study as an adjunctive treatment for major depressive disorder. In addition all subjects were treated with background antidepressant therapy prescribed by the investigator.
Subjects were entered into the study in one of 3 ways, based upon previous experience with a prior ALKS 5461 study: Subjects continuing from a prior ALKS 5461 study; Subjects who participated in the prospective lead-in for a prior ALKS 5461 study, but did not meet the entrance criteria; Subjects who did not participate in a prior ALKS 5461 study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ALKS 5461 | ALKS 5461 adjunctive treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2016 | Nov 21, 2018 |
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| Birmingham |
| Alabama |
| 35294 |
| United States |
| Alkermes Investigational Site | Tucson | Arizona | 85712 | United States |
| Alkermes Investigational Site | Little Rock | Arkansas | 72211 | United States |
| Alkermes Investigational Site | Bellflower | California | 90706 | United States |
| Alkermes Investigational Site | Beverly Hills | California | 90210 | United States |
| Alkermes Investigational Site | Carson | California | 90746 | United States |
| Alkermes Investigational Site | Garden Grove | California | 92845 | United States |
| Alkermes Investigational Site | Glendale | California | 91206 | United States |
| Alkermes Investigational Site | Los Alamitos | California | 90720 | United States |
| Alkermes Investigational Site | Los Angeles | California | 90024 | United States |
| Alkermes Investigational Site | National City | California | 91950 | United States |
| Alkermes Investigational Site | Oakland | California | 94612 | United States |
| Alkermes Investigational Site | Oceanside | California | 92056 | United States |
| Alkermes Investigational Site | Orange | California | 92868 | United States |
| Alkermes Investigational Site | Pico Rivera | California | 90660 | United States |
| Alkermes Investigational Site | Redlands | California | 92374 | United States |
| Alkermes Investigational Site | San Gabriel | California | 91776 | United States |
| Alkermes Investigational Site | Sherman Oaks | California | 91403 | United States |
| Alkermes Investigational Site | Temecula | California | 92591 | United States |
| Alkermes Investigational Site | Torrance | California | 90502 | United States |
| Alkermes Investigational Site | Upland | California | 91786 | United States |
| Alkermes Investigational Site | Colorado Springs | Colorado | 80910 | United States |
| Alkermes Investigational Site | Denver | Colorado | 80209 | United States |
| Alkermes Investigational Site | Hartford | Connecticut | 06106 | United States |
| Alkermes Investigational Site | Norwich | Connecticut | 06360 | United States |
| Alkermes Investigational Site | Bradenton | Florida | 34201 | United States |
| Alkermes Investigational Site | Coral Springs | Florida | 33067 | United States |
| Alkermes Investigational Site | Fort Myers | Florida | 33912 | United States |
| Alkermes Investigational Site | Gainesville | Florida | 32607 | United States |
| Alkermes Investigational Site | Hallandale | Florida | 33009 | United States |
| Alkermes Investigational Site | Hialeah | Florida | 33016 | United States |
| Alkermes Investigational Site | Jacksonville | Florida | 32256 | United States |
| Alkermes Investigational Site | Lauderhill | Florida | 33319 | United States |
| Alkermes Investigational Site | Maitland | Florida | 32751 | United States |
| Alkermes Investigational Site | Melbourne | Florida | 32901 | United States |
| Alkermes Investigational Site | North Miami | Florida | 33161 | United States |
| Alkermes Investigational Site | Oakland Park | Florida | 33334 | United States |
| Alkermes Investigational Site | Orlando | Florida | 32801 | United States |
| Alkermes Investigational Site | Tampa | Florida | 33613 | United States |
| Alkermes Investigational Site | The Villages | Florida | 32162 | United States |
| Alkermes Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Alkermes Investigational Site | Winter Haven | Florida | 33880 | United States |
| Alkermes Investigational Site | Alpharetta | Georgia | 30005 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30308 | United States |
| Alkermes Investigational Site | Decatur | Georgia | 30030 | United States |
| Alkermes Investigational Site | Smyrna | Georgia | 30080 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60634 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | United States |
| Alkermes Investigational Site | Deerfield | Illinois | 60015 | United States |
| Alkermes Investigational Site | Hoffman Estates | Illinois | 60169 | United States |
| Alkermes Investigational Site | Joliet | Illinois | 60435 | United States |
| Alkermes Investigational Site | Oak Brook | Illinois | 60523 | United States |
| Alkermes Investigational Site | Skokie | Illinois | 60076 | United States |
| Alkermes Investigational Site | Indianapolis | Indiana | 46260 | United States |
| Alkermes Investigational Site | Lafayette | Indiana | 47905 | United States |
| Alkermes Investigational Site | Newburgh | Indiana | 47630 | United States |
| Alkermes Investigational Site | Valparaiso | Indiana | 46383 | United States |
| Alkermes Investigational Site | Edgewood | Kentucky | 41017 | United States |
| Alkermes Investigational Site | Owensboro | Kentucky | 42301 | United States |
| Alkermes Investigational Site | Baltimore | Maryland | 21204 | United States |
| Alkermes Investigational Site | Baltimore | Maryland | 21208 | United States |
| Alkermes Investigational Site | Washington D.C. | Maryland | 20016 | United States |
| Alkermes Investigational Site | Belmont | Massachusetts | 02478 | United States |
| Alkermes Investigational Site | Brockton | Massachusetts | 02301 | United States |
| Alkermes Investigational Site | Watertown | Massachusetts | 02472 | United States |
| Alkermes Investigational Site | Worcester | Massachusetts | 01655 | United States |
| Alkermes Investigational Site | Flowood | Mississippi | 39232 | United States |
| Alkermes Investigational Site | O'Fallon | Missouri | 63368 | United States |
| Alkermes Investigational Site | Saint Charles | Missouri | 63304 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63109 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63141 | United States |
| Alkermes Investigational Site | Berlin | New Jersey | 80091 | United States |
| Alkermes Investigational Site | Cherry Hill | New Jersey | 08002 | United States |
| Alkermes Investigational Site | Princeton | New Jersey | 08540 | United States |
| Alkermes Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Alkermes Investigational Site | Brooklyn | New York | 11241 | United States |
| Alkermes Investigational Site | Jamaica | New York | 11432 | United States |
| Alkermes Investigational Site | Mount Kisco | New York | 10549 | United States |
| Alkermes Investigational Site | New York | New York | 10019 | United States |
| Alkermes Investigational Site | New York | New York | 10023 | United States |
| Alkermes Investigational Site | New York | New York | 10029 | United States |
| Alkermes Investigational Site | New York | New York | 10128 | United States |
| Alkermes Investigational Site | New York | New York | 10168 | United States |
| Alkermes Investigational Site | Staten Island | New York | 10305 | United States |
| Alkermes Investigational Site | Staten Island | New York | 10312 | United States |
| Alkermes Investigational Site | Charlotte | North Carolina | 28204 | United States |
| Alkermes Investigational Site | High Point | North Carolina | 27265 | United States |
| Alkermes Investigational Site | Beachwood | Ohio | 44122 | United States |
| Alkermes Investigational Site | Canton | Ohio | 44718 | United States |
| Alkermes Investigational Site | Cincinnati | Ohio | 45215 | United States |
| Alkermes Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | United States |
| Alkermes Investigational Site | Mason | Ohio | 45040 | United States |
| Alkermes Investigational Site | Middleburg Heights | Ohio | 44130 | United States |
| Alkermes Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Alkermes Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Alkermes Investigational Site | Portland | Oregon | 97210 | United States |
| Alkermes Investigational Site | Portland | Oregon | 97214 | United States |
| Alkermes Investigational Site | Salem | Oregon | 97301 | United States |
| Alkermes Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| Alkermes Investigational Site | Media | Pennsylvania | 19063 | United States |
| Alkermes Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Alkermes Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Alkermes Investigational Site | Lincoln | Rhode Island | 02865 | United States |
| Alkermes Investigational Site | Charleston | South Carolina | 29407 | United States |
| Alkermes Investigational Site | Memphis | Tennessee | 38119 | United States |
| Alkermes Investigational Site | Austin | Texas | 78731 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75231 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75390 | United States |
| Alkermes Investigational Site | DeSoto | Texas | 75115 | United States |
| Alkermes Investigational Site | Houston | Texas | 77081 | United States |
| Alkermes Investigational Site | Houston | Texas | 77098 | United States |
| Alkermes Investigational Site | San Antonio | Texas | 78229 | United States |
| Alkermes Investigational Site | Sugar Land | Texas | 77478 | United States |
| Alkermes Investigational Site | Wichita Falls | Texas | 76309 | United States |
| Alkermes Investigational Site | Clinton | Utah | 84015 | United States |
| Alkermes Investigational Site | Woodstock | Vermont | 05091 | United States |
| Alkermes Investigational Site | Bellevue | Washington | 98007 | United States |
| Alkermes Investigational Site | Seattle | Washington | 98104 | United States |
| Alkermes Investigational Site | Spokane | Washington | 99204 | United States |
| Alkermes Investigational Site | Middleton | Wisconsin | 53562 | United States |
| Alkermes Investigational Site | Waukesha | Wisconsin | 53188 | United States |
| Alkermes Investigational Site | Towong | Queensland | 4066 | Australia |
| Alkermes Investigational Site | Frankston | Victoria | 3199 | Australia |
| Alkermes Investigational Site | Melbourne | Victoria | 3004 | Australia |
| Alkermes Investigational Site | Burgas | 8001 | Bulgaria |
| Alkermes Investigational Site | Kazanlak | 6100 | Bulgaria |
| Alkermes Investigational Site | Sofia | 1113 | Bulgaria |
| Alkermes Investigational Site | Sofia | 1431 | Bulgaria |
| Alkermes Investigational Site | Sofia | 1632 | Bulgaria |
| Alkermes Investigational Site | Varna | 9020 | Bulgaria |
| Alkermes Investigational Site | Veliko Tarnovo | 5000 | Bulgaria |
| Alkermes Investigational Site | Vratsa | 3000 | Bulgaria |
| Alkermes Investigational Site | Penticton | British Columbia | V2A 4M4 | Canada |
| Alkermes Investigational Site | Halifax | Nova Scotia | B3S 1L8 | Canada |
| Alkermes Investigational Site | Gatineau | Quebec | J8T 8JL | Canada |
| Alkermes Investigational Site | Québec | G3K 2P8 | Canada |
| Alkermes Investigational Site | Oranienburg | Brandenburg | 16515 | Germany |
| Alkermes Investigational Site | Achim | 28832 | Germany |
| Alkermes Investigational Site | Berlin | 10245 | Germany |
| Alkermes Investigational Site | Berlin | 10365 | Germany |
| Alkermes Investigational Site | Berlin | 10629 | Germany |
| Alkermes Investigational Site | Ellwangen | 73479 | Germany |
| Alkermes Investigational Site | Freiburg im Breisgau | 79104 | Germany |
| Alkermes Investigational Site | Hanover | 30159 | Germany |
| Alkermes Investigational Site | Mainz | 55131 | Germany |
| Alkermes Investigational Site | Schwerin | 19053 | Germany |
| Alkermes Investigational Site | Stralsund | 18439 | Germany |
| Alkermes Investigational Site | Budapest | 1053 | Hungary |
| Alkermes Investigational Site | Budapest | 1135 | Hungary |
| Alkermes Investigational Site | Budapest | 1137 | Hungary |
| Alkermes Investigational Site | Bialystok | 15-879 | Poland |
| Alkermes Investigational Site | Gdansk | 80-438 | Poland |
| Alkermes Investigational Site | Gdansk | 80-546 | Poland |
| Alkermes Investigational Site | Gorlice | 38-300 | Poland |
| Alkermes Investigational Site | San Juan | 00918 | Puerto Rico |
| Alkermes Investigational Site | San Juan | 00926 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population includes all subjects who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ALKS 5461 | ALKS 5461 adjunctive treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Incidence of Adverse Events (AEs) | The safety population included all subjects who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
|
|
Up to 56 weeks
Not provided
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 | ALKS 5461 | ALKS 5461 adjunctive treatment | 2 | 1,485 | 47 | 1,485 | 1,124 | 1,485 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Seminoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
|
Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Stroynowski | Alkermes | 781-609-7000 | Eva.Stroynowski@alkermes.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2017 | Nov 21, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000618349 | ALKS 5461 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Poland |
|
| Australia |
|
| Bulgaria |
|
| Germany |
|