Clinical trial NCT02218008: A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
Official title: A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder (MDD)
depression
Alkermes
ALKS 5461
samidorphan
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 407
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 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 an 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 their 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 in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
timeFrame: Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect
measure: Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)
timeFrame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
measure: Change From Baseline to End of Treatment in the MADRS-10
timeFrame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
Secondary outcomes:
measure: Proportion of Patients Who Exhibited Treatment Response (MADRS-10)
timeFrame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
measure: Remission Rate
timeFrame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)
measure: Number of Subjects With Adverse Events (AEs)
timeFrame: 5-6 Weeks (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: Colton
country: United States
facility: Alkermes Investigational Site
state: California
city: Garden Grove
country: United States
facility: Alkermes Investigational Site
state: California
city: Los Angeles
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: Pico Rivera
country: United States
facility: Alkermes Investigational Site
state: California
city: San Gabriel
country: United States
facility: Alkermes Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Bradenton
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Fort Myers
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: Winter Haven
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Smyrna
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Flowood
country: United States
facility: Alkermes Investigational Site
state: Mississippi
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: Princeton
country: United States
facility: Alkermes Investigational Site
state: New Jersey
city: New York
country: United States
facility: Alkermes Investigational Site
state: New York
city: High Point
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Portland
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Memphis
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: DeSoto
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: 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: Gatineau
country: Canada
facility: Alkermes Investigational Site
city: Halifax
country: Canada
facility: Alkermes Investigational Site
city: Penticton
country: Canada
facility: Alkermes Investigational Site
city: Quebec
country: Canada
facility: Alkermes Investigational Site
city: Berlin
country: Germany
facility: Alkermes Investigational Site
city: Berlin
country: Germany
facility: Alkermes Investigational Site
city: Hannover
country: Germany
facility: Alkermes Investigational Site
city: Oranienburg
country: Germany
facility: Alkermes Investigational Site
city: Schwerin
country: Germany
facility: Alkermes Investigational Site
city: Stralsund
country: Germany
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: