Clinical trial NCT02158546: A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
Official title: A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Alkermes
ALKS 5461
Samidorphan
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of ALKS 5461.


Eligibility criteria: Inclusion Criteria:

* Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
* Agree to use an acceptable method of contraception for the duration of the study
* Have a Major Depressive Disorder (MDD) primary diagnosis
* Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
* Additional criteria may apply

Exclusion Criteria:

* 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 one course of electroconvulsive treatment during lifetime
* Have attempted suicide within the past 2 years
* Have a positive test for drugs of abuse
* Are pregnant, planning to become pregnant, or breastfeeding
* 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 60 days
* Additional criteria may apply

Primary outcomes:
measure: Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and week 6
Secondary outcomes:
measure: Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
timeFrame: 6 weeks
measure: Remission Rate
timeFrame: 6 weeks
measure: Number of Subjects With Adverse Events (AEs)
timeFrame: 6 weeks
Other outcomes:
Locations:
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: Glendale
country: United States
facility: Alkermes Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: Redlands
country: United States
facility: Alkermes Investigational Site
state: California
city: Temecula
country: United States
facility: Alkermes Investigational Site
state: California
city: Washington
country: United States
facility: Alkermes Investigational Site
state: District of Columbia
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: Leesburg
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Maitland
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Tampa
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Vernon Hills
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: Edgewood
country: United States
facility: Alkermes Investigational Site
state: Kentucky
city: Washington DC
country: United States
facility: Alkermes Investigational
state: Maryland
city: Brockton
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Alkermes Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: O'Fallon
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Cherry Hill
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Alkermes Investigational Site
state: New Mexico
city: Jamaica
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: Charlotte
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Beachwood
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: Mason
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Portland
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Salem
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Waukesha
country: United States
facility: Alkermes Investigational Site
state: Wisconsin
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 Tarnovo
country: Bulgaria
facility: Alkermes Investigational Site
city: Vratza
country: Bulgaria
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References: