Major Depressive Disorder Clinical Trial
Official title:
A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)
| Verified date | November 2018 |
| Source | Alkermes, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
| Status | Completed |
| Enrollment | 1485 |
| Est. completion date | November 20, 2017 |
| Est. primary completion date | November 20, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Agree to use an approved method of contraception for the duration of the study - Have the potential to safely benefit from the administration of ALKS 5461 - Have a diagnosis of major depressive disorder (MDD) - Additional criteria may apply Exclusion Criteria: - Have a positive test for drugs of abuse - Currently pregnant or breastfeeding - Have a current primary Axis-I disorder other than MDD - Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days - Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime - Have attempted suicide within the past 2 years - Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) - Have had a significant blood loss or blood donation within the past 60 days - Additional criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Alkermes Investigational Site | Frankston | Victoria |
| Australia | Alkermes Investigational Site | Melbourne | Victoria |
| Australia | Alkermes Investigational Site | Towong | Queensland |
| Bulgaria | Alkermes Investigational Site | Bourgas | |
| Bulgaria | Alkermes Investigational Site | Kazanlak | |
| Bulgaria | Alkermes Investigational Site | Sofia | |
| Bulgaria | Alkermes Investigational Site | Sofia | |
| Bulgaria | Alkermes Investigational Site | Sofia | |
| Bulgaria | Alkermes Investigational Site | Varna | |
| Bulgaria | Alkermes Investigational Site | Veliko Turnovo | |
| Bulgaria | Alkermes Investigational Site | Vratza | |
| Canada | Alkermes Investigational Site | Gatineau | Quebec |
| Canada | Alkermes Investigational Site | Halifax | Nova Scotia |
| Canada | Alkermes Investigational Site | Penticton | British Columbia |
| Canada | Alkermes Investigational Site | Quebec | |
| Germany | Alkermes Investigational Site | Achim | |
| Germany | Alkermes Investigational Site | Berlin | |
| Germany | Alkermes Investigational Site | Berlin | |
| Germany | Alkermes Investigational Site | Berlin | |
| Germany | Alkermes Investigational Site | Ellwangen | |
| Germany | Alkermes Investigational Site | Freiburg | |
| Germany | Alkermes Investigational Site | Hannover | |
| Germany | Alkermes Investigational Site | Mainz | |
| Germany | Alkermes Investigational Site | Oranienburg | Brandenburg |
| Germany | Alkermes Investigational Site | Schwerin | |
| Germany | Alkermes Investigational Site | Stralsund | |
| Hungary | Alkermes Investigational Site | Budapest | |
| Hungary | Alkermes Investigational Site | Budapest | |
| Hungary | Alkermes Investigational Site | Budapest | |
| Poland | Alkermes Investigational Site | Bialystok | |
| Poland | Alkermes Investigational Site | Gdansk | |
| Poland | Alkermes Investigational Site | Gdansk | |
| Poland | Alkermes Investigational Site | Gorlice | |
| Puerto Rico | Alkermes Investigational Site | San Juan | |
| Puerto Rico | Alkermes Investigational Site | San Juan | |
| United States | Alkermes Investigational Site | Albuquerque | New Mexico |
| United States | Alkermes Investigational Site | Allentown | Pennsylvania |
| United States | Alkermes Investigational Site | Alpharetta | Georgia |
| United States | Alkermes Investigational Site | Atlanta | Georgia |
| United States | Alkermes Investigational Site | Austin | Texas |
| United States | Alkermes Investigational Site | Baltimore | Maryland |
| United States | Alkermes Investigational Site | Baltimore | Maryland |
| United States | Alkermes Investigational Site | Beachwood | Ohio |
| United States | Alkermes Investigational Site | Bellevue | Washington |
| United States | Alkermes Investigational Site | Bellflower | California |
| United States | Alkermes Investigational Site | Belmont | Massachusetts |
| United States | Alkermes Investigational Site | Berlin | New Jersey |
| United States | Alkermes Investigational Site | Beverly Hills | California |
| United States | Alkermes Investigational Site | Birmingham | Alabama |
| United States | Alkermes Investigational Site | Birmingham | Alabama |
| United States | Alkermes Investigational Site | Bradenton | Florida |
| United States | Alkermes Investigational Site | Brockton | Massachusetts |
| United States | Alkermes Investigational Site | Brooklyn | New York |
| United States | Alkermes Investigational Site | Canton | Ohio |
| United States | Alkermes Investigational Site | Carson | California |
| United States | Alkermes Investigational Site | Charleston | South Carolina |
| United States | Alkermes Investigational Site | Charlotte | North Carolina |
| United States | Alkermes Investigational Site | Cherry Hill | New Jersey |
| United States | Alkermes Investigational Site | Chicago | Illinois |
| United States | Alkermes Investigational Site | Chicago | Illinois |
| United States | Alkermes Investigational Site | Cincinnati | Ohio |
| United States | Alkermes Investigational Site | Cincinnati | Ohio |
| United States | Alkermes Investigational Site | Clinton | Utah |
| United States | Alkermes Investigational Site | Colorado Springs | Colorado |
| United States | Alkermes Investigational Site | Coral Springs | Florida |
| United States | Alkermes Investigational Site | Dallas | Texas |
| United States | Alkermes Investigational Site | Dallas | Texas |
| United States | Alkermes Investigational Site | Dayton | Ohio |
| United States | Alkermes Investigational Site | Decatur | Georgia |
| United States | Alkermes Investigational Site | Deerfield | Illinois |
| United States | Alkermes Investigational Site | Denver | Colorado |
| United States | Alkermes Investigational Site | DeSoto | Texas |
| United States | Alkermes Investigational Site | Edgewood | Kentucky |
| United States | Alkermes Investigational Site | Flowood | Mississippi |
| United States | Alkermes Investigational Site | Fort Myers | Florida |
| United States | Alkermes Investigational Site | Gainesville | Florida |
| United States | Alkermes Investigational Site | Garden Grove | California |
| United States | Alkermes Investigational Site | Glendale | California |
| United States | Alkermes Investigational Site | Hallandale Beach | Florida |
| United States | Alkermes Investigational Site | Hartford | Connecticut |
| United States | Alkermes Investigational Site | Hialeah | Florida |
| United States | Alkermes Investigational Site | High Point | North Carolina |
| United States | Alkermes Investigational Site | Hoffman Estates | Illinois |
| United States | Alkermes Investigational Site | Houston | Texas |
| United States | Alkermes Investigational Site | Houston | Texas |
| United States | Alkermes Investigational Site | Indianapolis | Indiana |
| United States | Alkermes Investigational Site | Jacksonville | Florida |
| United States | Alkermes Investigational Site | Jamaica | New York |
| United States | Alkermes Investigational Site | Joliet | Illinois |
| United States | Alkermes Investigational Site | Lafayette | Indiana |
| United States | Alkermes Investigational Site | Lauderhill | Florida |
| United States | Alkermes Investigational Site | Lincoln | Rhode Island |
| United States | Alkermes Investigational Site | Little Rock | Arkansas |
| United States | Alkermes Investigational Site | Los Alamitos | California |
| United States | Alkermes Investigational Site | Los Angeles | California |
| United States | Alkermes Investigational Site | Maitland | Florida |
| United States | Alkermes Investigational Site | Mason | Ohio |
| United States | Alkermes Investigational Site | Media | Pennsylvania |
| United States | Alkermes Investigational Site | Melbourne | Florida |
| United States | Alkermes Investigational Site | Memphis | Tennessee |
| United States | Alkermes Investigational Site | Middleburg Heights | Ohio |
| United States | Alkermes Investigational Site | Middleton | Wisconsin |
| United States | Alkermes Investigational Site | Mount Kisco | New York |
| United States | Alkermes Investigational Site | National City | California |
| United States | Alkermes Investigational Site | New York | New York |
| United States | Alkermes Investigational Site | New York | New York |
| United States | Alkermes Investigational Site | New York | New York |
| United States | Alkermes Investigational Site | New York | New York |
| United States | Alkermes Investigational Site | New York | New York |
| United States | Alkermes Investigational Site | Newburgh | Indiana |
| United States | Alkermes Investigational Site | North Miami | Florida |
| United States | Alkermes Investigational Site | Norwich | Connecticut |
| United States | Alkermes Investigational Site | O'Fallon | Missouri |
| United States | Alkermes Investigational Site | Oak Brook | Illinois |
| United States | Alkermes Investigational Site | Oakland | California |
| United States | Alkermes Investigational Site | Oakland Park | Florida |
| United States | Alkermes Investigational Site | Oceanside | California |
| United States | Alkermes Investigational Site | Oklahoma City | Oklahoma |
| United States | Alkermes Investigational Site | Oklahoma City | Oklahoma |
| United States | Alkermes Investigational Site | Orange | California |
| United States | Alkermes Investigational Site | Orlando | Florida |
| United States | Alkermes Investigational Site | Owensboro | Kentucky |
| United States | Alkermes Investigational Site | Philadelphia | Pennsylvania |
| United States | Alkermes Investigational Site | Philadelphia | Pennsylvania |
| United States | Alkermes Investigational Site | Pico Rivera | California |
| United States | Alkermes Investigational Site | Portland | Oregon |
| United States | Alkermes Investigational Site | Portland | Oregon |
| United States | Alkermes Investigational Site | Princeton | New Jersey |
| United States | Alkermes Investigational Site | Redlands | California |
| United States | Alkermes Investigational Site | Saint Charles | Missouri |
| United States | Alkermes Investigational Site | Saint Louis | Missouri |
| United States | Alkermes Investigational Site | Saint Louis | Missouri |
| United States | Alkermes Investigational Site | Salem | Oregon |
| United States | Alkermes Investigational Site | San Antonio | Texas |
| United States | Alkermes Investigational Site | San Gabriel | California |
| United States | Alkermes Investigational Site | Seattle | Washington |
| United States | Alkermes Investigational Site | Sherman Oaks | California |
| United States | Alkermes Investigational Site | Skokie | Illinois |
| United States | Alkermes Investigational Site | Smyrna | Georgia |
| United States | Alkermes Investigational Site | Spokane | Washington |
| United States | Alkermes Investigational Site | Staten Island | New York |
| United States | Alkermes Investigational Site | Staten Island | New York |
| United States | Alkermes Investigational Site | Sugar Land | Texas |
| United States | Alkermes Investigational Site | Tampa | Florida |
| United States | Alkermes Investigational Site | Temecula | California |
| United States | Alkermes Investigational Site | The Villages | Florida |
| United States | Alkermes Investigational Site | Torrance | California |
| United States | Alkermes Investigational Site | Tucson | Arizona |
| United States | Alkermes Investigational Site | Upland | California |
| United States | Alkermes Investigational Site | Valparaiso | Indiana |
| United States | Alkermes Investigational Site | Washington D.C. | Maryland |
| United States | Alkermes Investigational Site | Watertown | Massachusetts |
| United States | Alkermes Investigational Site | Waukesha | Wisconsin |
| United States | Alkermes Investigational Site | West Palm Beach | Florida |
| United States | Alkermes Investigational Site | Wichita Falls | Texas |
| United States | Alkermes Investigational Site | Winter Haven | Florida |
| United States | Alkermes Investigational Site | Woodstock | Vermont |
| United States | Alkermes Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Alkermes, Inc. |
United States, Australia, Bulgaria, Canada, Germany, Hungary, Poland, Puerto Rico,
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