Clinical trial NCT03610048: A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
Official title: A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Refractory Major Depressive Disorder
Keywords: Alkermes
Major depressive disorder
Depression
ALKS 5461
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label
Primary purpose: TREATMENT

Brief summary: This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 68 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Los Alamitos
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Alkermes Investigational Site
state: California
city: Redlands
country: United States
facility: Alkermes Investigational Site
state: California
city: Santa Ana
country: United States
facility: Alkermes Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Alkermes Investigational Site
state: California
city: Temecula
country: United States
facility: Alkermes Investigational Site
state: California
city: Hollywood
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Palm Bay
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Pikesville
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: O'Fallon
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Jamaica
country: United States
facility: Alkermes Investigational Site
state: New York
city: Mount Kisco
country: United States
facility: Alkermes Investigational Site
state: New York
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Allentown
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Woodstock
country: United States
facility: Alkermes Investigational Site
state: Vermont
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Frankston
country: Australia
facility: Alkermes Investigational Site
state: Victoria
city: Noble Park
country: Australia
facility: Alkermes Investigational Site
state: Victoria
city: Richmond
country: Australia
facility: Alkermes Investigational Site
state: Victoria
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
city: San Juan
country: Puerto Rico
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Alkermes Medical Director
role: STUDY_DIRECTOR
References: