Refractory Major Depressive Disorder Clinical Trial
Official title:
A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder
| Verified date | June 2021 |
| Source | Alkermes, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
| Status | Terminated |
| Enrollment | 175 |
| Est. completion date | May 1, 2020 |
| Est. primary completion date | May 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 72 Years |
| Eligibility | Inclusion Criteria: - Completed study ALK5461-217 - Be willing to abide by the contraception requirements as outlined in the study protocol - Be willing and able to follow the study procedures and visits as outlined in the protocol - Additional criteria may apply Exclusion Criteria: - Pregnant, planning to become pregnant, or breastfeeding - A positive urine drug test for drugs of abuse - Poses a current suicide risk - Additional criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Alkermes Investigational Site | Frankston | Victoria |
| Australia | Alkermes Investigational Site | Noble Park | Victoria |
| Australia | Alkermes Investigational Site | Richmond | Victoria |
| Puerto Rico | Alkermes Investigational Site | San Juan | |
| Puerto Rico | Alkermes Investigational Site | San Juan | |
| United States | Alkermes Investigational Site | Allentown | Pennsylvania |
| United States | Alkermes Investigational Site | Atlanta | Georgia |
| United States | Alkermes Investigational Site | Bellevue | Washington |
| United States | Alkermes Investigational Site | Canton | Ohio |
| United States | Alkermes Investigational Site | Cincinnati | Ohio |
| United States | Alkermes Investigational Site | Dallas | Texas |
| United States | Alkermes Investigational Site | Decatur | Georgia |
| United States | Alkermes Investigational Site | DeSoto | Texas |
| United States | Alkermes Investigational Site | Hollywood | Florida |
| United States | Alkermes Investigational Site | Jacksonville | Florida |
| United States | Alkermes Investigational Site | Jamaica | New York |
| United States | Alkermes Investigational Site | Lauderhill | Florida |
| United States | Alkermes Investigational Site | Little Rock | Arkansas |
| United States | Alkermes Investigational Site | Los Alamitos | California |
| United States | Alkermes Investigational Site | Memphis | Tennessee |
| United States | Alkermes Investigational Site | Mount Kisco | New York |
| United States | Alkermes Investigational Site | O'Fallon | Missouri |
| United States | Alkermes Investigational Site | Oceanside | California |
| United States | Alkermes Investigational Site | Oklahoma City | Oklahoma |
| United States | Alkermes Investigational Site | Orlando | Florida |
| United States | Alkermes Investigational Site | Palm Bay | Florida |
| United States | Alkermes Investigational Site | Pico Rivera | California |
| United States | Alkermes Investigational Site | Pikesville | Maryland |
| United States | Alkermes Investigational Site | Redlands | California |
| United States | Alkermes Investigational Site | Santa Ana | California |
| United States | Alkermes Investigational Site | Sherman Oaks | California |
| United States | Alkermes Investigational Site | Temecula | California |
| United States | Alkermes Investigational Site | Tucson | Arizona |
| United States | Alkermes Investigational Site | Woodstock | Vermont |
| Lead Sponsor | Collaborator |
|---|---|
| Alkermes, Inc. |
United States, Australia, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Number and percentage of subjects experiencing TEAEs | Up to 68 weeks |