Clinical trial NCT02158533: A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Official title: A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 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: 385
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 Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and 5 weeks for each stage
Secondary outcomes:
measure: Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
timeFrame: Baseline and 5 weeks for each stage
measure: Remission Rate
timeFrame: Baseline and 5 weeks for each stage
measure: Number of Subjects With Adverse Events (AEs)
timeFrame: 5 weeks for Stage 1 and 6 weeks for Stage 2
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alkermes Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Carson
country: United States
facility: Alkermes Investigational Site
state: California
city: National City
country: United States
facility: Alkermes Investigational Site
state: California
city: Orange
country: United States
facility: Alkermes Investigational Site
state: California
city: Sherman Oaks
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: Hartford
country: United States
facility: Alkermes Investigational Site
state: Connecticut
city: Norwich
country: United States
facility: Alkermes Investigational Site
state: Connecticut
city: Coral Springs
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Gainesville
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: Alpharetta
country: United States
facility: Alkermes, Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Joliet
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Newburgh
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Valparaiso
country: United States
facility: Alkermes Investigational Site
state: Indiana
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: Berlin
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: Brooklyn
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: Staten Island
country: United States
facility: Alkermes Investigational Site
state: New York
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dayton
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: 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: Lincoln
country: United States
facility: Alkermes Investigational Site
state: Rhode Island
city: Austin
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: Woodstock
country: United States
facility: Alkermes Investigational Site
state: Vermont
city: Middleton
country: United States
facility: Alkermes Investigational Site
state: Wisconsin
city: Brisbane
country: Australia
facility: Alkermes Investigational Site
state: Queensland
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: Penticton
country: Canada
facility: Alkermes Investigational Site
state: British Columbia
city: Gatineau
country: Canada
facility: Alkermes Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Alkermes Investigational Site
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References: