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Completed Phase 3 Interventional Results available

A Long-Term Safety Study of ALKS 5461

ClinicalTrials.gov ID: NCT02141399

Public ClinicalTrials.gov record NCT02141399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 30, 2026, 1:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT02141399
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alkermes, Inc.
Industry
Enrollment
1,485 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2014 (Actual)
Primary completion
Nov 20, 2017 (Actual)
Completion
Nov 20, 2017 (Actual)
Last update posted
Dec 14, 2018

2014 – 2017

United States locations

U.S. sites
123
U.S. states
31
U.S. cities
108
Facility City State ZIP Site status
Alkermes Investigational Site Birmingham Alabama 35226 —
Alkermes Investigational Site Birmingham Alabama 35294 —
Alkermes Investigational Site Tucson Arizona 85712 —
Alkermes Investigational Site Little Rock Arkansas 72211 —
Alkermes Investigational Site Bellflower California 90706 —
Alkermes Investigational Site Beverly Hills California 90210 —
Alkermes Investigational Site Carson California 90746 —
Alkermes Investigational Site Garden Grove California 92845 —
Alkermes Investigational Site Glendale California 91206 —
Alkermes Investigational Site Los Alamitos California 90720 —
Alkermes Investigational Site Los Angeles California 90024 —
Alkermes Investigational Site National City California 91950 —
Alkermes Investigational Site Oakland California 94612 —
Alkermes Investigational Site Oceanside California 92056 —
Alkermes Investigational Site Orange California 92868 —
Alkermes Investigational Site Pico Rivera California 90660 —
Alkermes Investigational Site Redlands California 92374 —
Alkermes Investigational Site San Gabriel California 91776 —
Alkermes Investigational Site Sherman Oaks California 91403 —
Alkermes Investigational Site Temecula California 92591 —
Alkermes Investigational Site Torrance California 90502 —
Alkermes Investigational Site Upland California 91786 —
Alkermes Investigational Site Colorado Springs Colorado 80910 —
Alkermes Investigational Site Denver Colorado 80209 —
Alkermes Investigational Site Hartford Connecticut 06106 —
Alkermes Investigational Site Norwich Connecticut 06360 —
Alkermes Investigational Site Bradenton Florida 34201 —
Alkermes Investigational Site Coral Springs Florida 33067 —
Alkermes Investigational Site Fort Myers Florida 33912 —
Alkermes Investigational Site Gainesville Florida 32607 —
Alkermes Investigational Site Hallandale Florida 33009 —
Alkermes Investigational Site Hialeah Florida 33016 —
Alkermes Investigational Site Jacksonville Florida 32256 —
Alkermes Investigational Site Lauderhill Florida 33319 —
Alkermes Investigational Site Maitland Florida 32751 —
Alkermes Investigational Site Melbourne Florida 32901 —
Alkermes Investigational Site North Miami Florida 33161 —
Alkermes Investigational Site Oakland Park Florida 33334 —
Alkermes Investigational Site Orlando Florida 32801 —
Alkermes Investigational Site Tampa Florida 33613 —
Alkermes Investigational Site The Villages Florida 32162 —
Alkermes Investigational Site West Palm Beach Florida 33407 —
Alkermes Investigational Site Winter Haven Florida 33880 —
Alkermes Investigational Site Alpharetta Georgia 30005 —
Alkermes Investigational Site Atlanta Georgia 30308 —
Alkermes Investigational Site Decatur Georgia 30030 —
Alkermes Investigational Site Smyrna Georgia 30080 —
Alkermes Investigational Site Chicago Illinois 60634 —
Alkermes Investigational Site Chicago Illinois 60640 —
Alkermes Investigational Site Deerfield Illinois 60015 —
Alkermes Investigational Site Hoffman Estates Illinois 60169 —
Alkermes Investigational Site Joliet Illinois 60435 —
Alkermes Investigational Site Oak Brook Illinois 60523 —
Alkermes Investigational Site Skokie Illinois 60076 —
Alkermes Investigational Site Indianapolis Indiana 46260 —
Alkermes Investigational Site Lafayette Indiana 47905 —
Alkermes Investigational Site Newburgh Indiana 47630 —
Alkermes Investigational Site Valparaiso Indiana 46383 —
Alkermes Investigational Site Edgewood Kentucky 41017 —
Alkermes Investigational Site Owensboro Kentucky 42301 —
Alkermes Investigational Site Baltimore Maryland 21204 —
Alkermes Investigational Site Baltimore Maryland 21208 —
Alkermes Investigational Site Washington D.C. Maryland 20016 —
Alkermes Investigational Site Belmont Massachusetts 02478 —
Alkermes Investigational Site Brockton Massachusetts 02301 —
Alkermes Investigational Site Watertown Massachusetts 02472 —
Alkermes Investigational Site Worcester Massachusetts 01655 —
Alkermes Investigational Site Flowood Mississippi 39232 —
Alkermes Investigational Site O'Fallon Missouri 63368 —
Alkermes Investigational Site Saint Charles Missouri 63304 —
Alkermes Investigational Site St Louis Missouri 63109 —
Alkermes Investigational Site St Louis Missouri 63141 —
Alkermes Investigational Site Berlin New Jersey 80091 —
Alkermes Investigational Site Cherry Hill New Jersey 08002 —
Alkermes Investigational Site Princeton New Jersey 08540 —
Alkermes Investigational Site Albuquerque New Mexico 87109 —
Alkermes Investigational Site Brooklyn New York 11241 —
Alkermes Investigational Site Jamaica New York 11432 —
Alkermes Investigational Site Mount Kisco New York 10549 —
Alkermes Investigational Site New York New York 10019 —
Alkermes Investigational Site New York New York 10023 —
Alkermes Investigational Site New York New York 10029 —
Alkermes Investigational Site New York New York 10128 —
Alkermes Investigational Site New York New York 10168 —
Alkermes Investigational Site Staten Island New York 10305 —
Alkermes Investigational Site Staten Island New York 10312 —
Alkermes Investigational Site Charlotte North Carolina 28204 —
Alkermes Investigational Site High Point North Carolina 27265 —
Alkermes Investigational Site Beachwood Ohio 44122 —
Alkermes Investigational Site Canton Ohio 44718 —
Alkermes Investigational Site Cincinnati Ohio 45215 —
Alkermes Investigational Site Cincinnati Ohio 45227 —
Alkermes Investigational Site Dayton Ohio 45417 —
Alkermes Investigational Site Mason Ohio 45040 —
Alkermes Investigational Site Middleburg Heights Ohio 44130 —
Alkermes Investigational Site Oklahoma City Oklahoma 73103 —
Alkermes Investigational Site Oklahoma City Oklahoma 73112 —
Alkermes Investigational Site Portland Oregon 97210 —
Alkermes Investigational Site Portland Oregon 97214 —
Alkermes Investigational Site Salem Oregon 97301 —
Alkermes Investigational Site Allentown Pennsylvania 18104 —
Alkermes Investigational Site Media Pennsylvania 19063 —
Alkermes Investigational Site Philadelphia Pennsylvania 19104 —
Alkermes Investigational Site Philadelphia Pennsylvania 19107 —
Alkermes Investigational Site Lincoln Rhode Island 02865 —
Alkermes Investigational Site Charleston South Carolina 29407 —
Alkermes Investigational Site Memphis Tennessee 38119 —
Alkermes Investigational Site Austin Texas 78731 —
Alkermes Investigational Site Dallas Texas 75231 —
Alkermes Investigational Site Dallas Texas 75390 —
Alkermes Investigational Site DeSoto Texas 75115 —
Alkermes Investigational Site Houston Texas 77081 —
Alkermes Investigational Site Houston Texas 77098 —
Alkermes Investigational Site San Antonio Texas 78229 —
Alkermes Investigational Site Sugar Land Texas 77478 —
Alkermes Investigational Site Wichita Falls Texas 76309 —
Alkermes Investigational Site Clinton Utah 84015 —
Alkermes Investigational Site Woodstock Vermont 05091 —
Alkermes Investigational Site Bellevue Washington 98007 —
Alkermes Investigational Site Seattle Washington 98104 —
Alkermes Investigational Site Spokane Washington 99204 —
Alkermes Investigational Site Middleton Wisconsin 53562 —
Alkermes Investigational Site Waukesha Wisconsin 53188 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02141399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 14, 2018 · Synced Sep 30, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02141399 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →