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Completed Phase 3 Interventional Results available

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

ClinicalTrials.gov ID: NCT02158546

Public ClinicalTrials.gov record NCT02158546. 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 Oct 19, 2026, 3:15 AM 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 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 Study)

Brief summary

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

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

Study identification

NCT ID
NCT02158546
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alkermes, Inc.
Industry
Enrollment
447 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 (Type not available)
Primary completion
Dec 2015 (Actual)
Completion
Dec 2015 (Actual)
Last update posted
Jun 25, 2019

2014 – 2015

United States locations

U.S. sites
50
U.S. states
23
U.S. cities
48
Facility City State ZIP Site status
Alkermes Investigational Site Little Rock Arkansas 72211 —
Alkermes Investigational Site Bellflower California 90706 —
Alkermes Investigational Site Beverly Hills California 90210 —
Alkermes Investigational Site Glendale California 91206 —
Alkermes Investigational Site Los Alamitos California 90720 —
Alkermes Investigational Site Orange California 92868 —
Alkermes Investigational Site Redlands California 92374 —
Alkermes Investigational Site Temecula California 92591 —
Alkermes Investigational Site Washington D.C. District of Columbia 20016 —
Alkermes Investigational Site Hallandale Florida 33009 —
Alkermes Investigational Site Hialeah Florida 33016 —
Alkermes Investigational Site Jacksonville Florida 32256 —
Alkermes Investigational Site Leesburg Florida 34748 —
Alkermes Investigational Site Maitland Florida 32751 —
Alkermes Investigational Site Tampa Florida 33613 —
Alkermes Investigational Site Atlanta Georgia 30331 —
Alkermes Investigational Site Chicago Illinois 60634 —
Alkermes Investigational Site Oak Brook Illinois 60523 —
Alkermes Investigational Site Vernon Hills Illinois 60061 —
Alkermes Investigational Site Indianapolis Indiana 46260 —
Alkermes Investigational Site Lafayette Indiana 47905 —
Alkermes Investigational Site Edgewood Kentucky 41017 —
Alkermes Investigational Washington DC Maryland 20016 —
Alkermes Investigational Site Brockton Massachusetts 02301 —
Alkermes Investigational Site Watertown Massachusetts 02472 —
Alkermes Investigational Site Kansas City Missouri 64114 —
Alkermes Investigational Site O'Fallon Missouri 63368 —
Alkermes Investigational Site St Louis Missouri 63109 —
Alkermes Investigational Site Cherry Hill New Jersey 08002 —
Alkermes Investigational Site Albuquerque New Mexico 87109 —
Alkermes Investigational Site Jamaica New York 11432 —
Alkermes Investigational Site New York New York 10023 —
Alkermes Investigational Site Staten Island New York 10312 —
Alkermes Investigational Site Charlotte North Carolina 28204 —
Alkermes Investigational Site Beachwood Ohio 44122 —
Alkermes Investigational Site Cincinnati Ohio 45215 —
Alkermes Investigational Site Cincinnati Ohio 45227 —
Alkermes Investigational Site Mason Ohio 45040 —
Alkermes Investigational Site Middleburg Heights Ohio 44130 —
Alkermes Investigational Site Portland Oregon 97210 —
Alkermes Investigational Site Salem Oregon 97301 —
Alkermes Investigational Site Philadelphia Pennsylvania 19104 —
Alkermes Investigational Site Charleston South Carolina 29407 —
Alkermes Investigational Site Memphis Tennessee 38119 —
Alkermes Investigational Site Dallas Texas 75231 —
Alkermes Investigational Site Dallas Texas 75309 —
Alkermes Investigational Site Houston Texas 77098 —
Alkermes Investigational Site Sugar Land Texas 77478 —
Alkermes Investigational Site Bellevue Washington 98007 —
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 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02158546, 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 Jun 25, 2019 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02158546 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →