Clinical trial NCT02141399: A Long-Term Safety Study of ALKS 5461
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-19
Enrollment: 1485
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alkermes Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Alkermes Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Alkermes Investigational Site
state: Arkansas
city: Bellflower
country: United States
facility: Alkermes Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Alkermes Investigational Site
state: California
city: Carson
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Glendale
country: United States
facility: Alkermes Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Alkermes Investigational Site
state: California
city: Los Angeles
country: United States
facility: Alkermes Investigational Site
state: California
city: National City
country: United States
facility: Alkermes Investigational Site
state: California
city: Oakland
country: United States
facility: Alkermes Investigational Site
state: California
city: Oceanside
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
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: San Gabriel
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: Torrance
country: United States
facility: Alkermes Investigational Site
state: California
city: Upland
country: United States
facility: Alkermes Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Denver
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Hartford
country: United States
facility: Alkermes Investigational Site
state: Connecticut
city: Norwich
country: United States
facility: Alkermes Investigational Site
state: Connecticut
city: Bradenton
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Coral Springs
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Hallandale Beach
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Hialeah
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: Maitland
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Alkermes Investigational Site
state: Florida
city: North Miami
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Orlando
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Tampa
country: United States
facility: Alkermes Investigational Site
state: Florida
city: The Villages
country: United States
facility: Alkermes Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Smyrna
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Deerfield
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Joliet
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Newburgh
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Valparaiso
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Edgewood
country: United States
facility: Alkermes Investigational Site
state: Kentucky
city: Owensboro
country: United States
facility: Alkermes Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: Washington D.C.
country: United States
facility: Alkermes Investigational Site
state: Maryland
city: Belmont
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Brockton
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Flowood
country: United States
facility: Alkermes Investigational Site
state: Mississippi
city: O'Fallon
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Charles
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Berlin
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Cherry Hill
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Princeton
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Alkermes Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: Alkermes Investigational Site
state: New York
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: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: Staten Island
country: United States
facility: Alkermes Investigational Site
state: New York
city: Staten Island
country: United States
facility: Alkermes Investigational Site
state: New York
city: Charlotte
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Mason
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Portland
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Salem
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Media
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Alkermes Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Clinton
country: United States
facility: Alkermes Investigational Site
state: Utah
city: Woodstock
country: United States
facility: Alkermes Investigational Site
state: Vermont
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Seattle
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Spokane
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Middleton
country: United States
facility: Alkermes Investigational Site
state: Wisconsin
city: Waukesha
country: United States
facility: Alkermes Investigational Site
state: Wisconsin
city: Towong
country: Australia
facility: Alkermes Investigational Site
state: Queensland
city: Frankston
country: Australia
facility: Alkermes Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Alkermes Investigational Site
state: Victoria
city: Bourgas
country: Bulgaria
facility: Alkermes Investigational Site
city: Kazanlak
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Varna
country: Bulgaria
facility: Alkermes Investigational Site
city: Veliko Turnovo
country: Bulgaria
facility: Alkermes Investigational Site
city: Vratza
country: Bulgaria
facility: Alkermes Investigational Site
city: Penticton
country: Canada
facility: Alkermes Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: Alkermes Investigational Site
state: Nova Scotia
city: Gatineau
country: Canada
facility: Alkermes Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Alkermes Investigational Site
city: Oranienburg
country: Germany
facility: Alkermes Investigational Site
state: Brandenburg
city: Achim
country: Germany
facility: Alkermes Investigational Site
city: Berlin
country: Germany
facility: Alkermes Investigational Site
city: Berlin
country: Germany
facility: Alkermes Investigational Site
city: Berlin
country: Germany
facility: Alkermes Investigational Site
city: Ellwangen
country: Germany
facility: Alkermes Investigational Site
city: Freiburg
country: Germany
facility: Alkermes Investigational Site
city: Hannover
country: Germany
facility: Alkermes Investigational Site
city: Mainz
country: Germany
facility: Alkermes Investigational Site
city: Schwerin
country: Germany
facility: Alkermes Investigational Site
city: Stralsund
country: Germany
facility: Alkermes Investigational Site
city: Budapest
country: Hungary
facility: Alkermes Investigational Site
city: Budapest
country: Hungary
facility: Alkermes Investigational Site
city: Budapest
country: Hungary
facility: Alkermes Investigational Site
city: Bialystok
country: Poland
facility: Alkermes Investigational Site
city: Gdansk
country: Poland
facility: Alkermes Investigational Site
city: Gdansk
country: Poland
facility: Alkermes Investigational Site
city: Gorlice
country: Poland
facility: Alkermes Investigational Site
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: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References: