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Clinical Trials
NCT02141399

A Long-Term Safety Study of ALKS 5461

Last Updated: 2018-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-11-20

Brief Summary

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

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALKS 5461

Group Type EXPERIMENTAL

ALKS 5461

Intervention Type DRUG

Sublingual tablet, taken daily

Interventions

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ALKS 5461

Sublingual tablet, taken daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjeev Pathak, MD

Role: STUDY_DIRECTOR

Alkermes, Inc.

Locations

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Alkermes Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Bellflower, California, United States

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Beverly Hills, California, United States

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Carson, California, United States

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Garden Grove, California, United States

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Glendale, California, United States

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Los Alamitos, California, United States

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Los Angeles, California, United States

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National City, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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Orange, California, United States

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Pico Rivera, California, United States

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Redlands, California, United States

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San Gabriel, California, United States

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Sherman Oaks, California, United States

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Temecula, California, United States

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Torrance, California, United States

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Upland, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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Norwich, Connecticut, United States

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Bradenton, Florida, United States

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Coral Springs, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Hallandale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Lauderhill, Florida, United States

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Maitland, Florida, United States

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Melbourne, Florida, United States

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North Miami, Florida, United States

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Oakland Park, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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The Villages, Florida, United States

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West Palm Beach, Florida, United States

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Winter Haven, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Smyrna, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Deerfield, Illinois, United States

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Hoffman Estates, Illinois, United States

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Joliet, Illinois, United States

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Oak Brook, Illinois, United States

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Skokie, Illinois, United States

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Indianapolis, Indiana, United States

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Lafayette, Indiana, United States

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Newburgh, Indiana, United States

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Valparaiso, Indiana, United States

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Edgewood, Kentucky, United States

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Owensboro, Kentucky, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Washington D.C., Maryland, United States

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Belmont, Massachusetts, United States

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Brockton, Massachusetts, United States

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Watertown, Massachusetts, United States

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Worcester, Massachusetts, United States

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Flowood, Mississippi, United States

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O'Fallon, Missouri, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Berlin, New Jersey, United States

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Cherry Hill, New Jersey, United States

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Princeton, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Jamaica, New York, United States

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