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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-4 Study

ClinicalTrials.gov ID: NCT02158533

Public ClinicalTrials.gov record NCT02158533. 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 30, 2026, 1:37 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 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 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
NCT02158533
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alkermes, Inc.
Industry
Enrollment
385 participants

Conditions and interventions

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
Aug 14, 2019

2014 – 2015

United States locations

U.S. sites
42
U.S. states
19
U.S. cities
40
Facility City State ZIP Site status
Alkermes Investigational Site Birmingham Alabama 35226 —
Alkermes Investigational Site Tucson Arizona 85712 —
Alkermes Investigational Site Carson California 90746 —
Alkermes Investigational Site National City California 91950 —
Alkermes Investigational Site Orange California 92868 —
Alkermes Investigational Site Sherman Oaks California 91403 —
Alkermes Investigational Site Torrance California 90502 —
Alkermes Investigational Site Upland California 91786 —
Alkermes Investigational Site Hartford Connecticut 06106 —
Alkermes Investigational Site Norwich Connecticut 06360 —
Alkermes Investigational Site Coral Springs Florida 33067 —
Alkermes Investigational Site Gainesville Florida 32607 —
Alkermes Investigational Site Lauderhill Florida 33319 —
Alkermes Investigational Site Orlando Florida 32801 —
Alkermes, Investigational Site Alpharetta Georgia 30005 —
Alkermes Investigational Site Decatur Georgia 30030 —
Alkermes Investigational Site Chicago Illinois 60640 —
Alkermes Investigational Site Joliet Illinois 60435 —
Alkermes Investigational Site Skokie Illinois 60076 —
Alkermes Investigational Site Newburgh Indiana 47630 —
Alkermes Investigational Site Valparaiso Indiana 46383 —
Alkermes Investigational Site Owensboro Kentucky 42301 —
Alkermes Investigational Site Baltimore Maryland 21208 —
Alkermes Investigational Site Baltimore Maryland 21285 —
Alkermes Investigational Site Berlin New Jersey 08009 —
Alkermes Investigational Site Brooklyn New York 11241 —
Alkermes Investigational Site Mount Kisco New York 10549 —
Alkermes Investigational Site New York New York 10128 —
Alkermes Investigational Site Staten Island New York 10305 —
Alkermes Investigational Site Canton Ohio 44718 —
Alkermes Investigational Site Dayton Ohio 45417 —
Alkermes Investigational Site Oklahoma City Oklahoma 73103 —
Alkermes Investigational Site Oklahoma City Oklahoma 73112 —
Alkermes Investigational Site Allentown Pennsylvania 18104 —
Alkermes Investigational Site Media Pennsylvania 19063 —
Alkermes Investigational Site Philadelphia Pennsylvania 19107 —
Alkermes Investigational Site Lincoln Rhode Island 02865 —
Alkermes Investigational Site Austin Texas 78731 —
Alkermes Investigational Site Houston Texas 77081 —
Alkermes Investigational Site San Antonio Texas 78229 —
Alkermes Investigational Site Woodstock Vermont 05091 —
Alkermes Investigational Site Middleton Wisconsin 53562 —

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 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02158533, 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 Aug 14, 2019 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02158533 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →