Clinical trialNCT03188185CompletedPhase 3Interventional

A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

SponsorAlkermes, Inc.Enrollment278Major Depressive Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Sanjeev Pathak, MD
Alkermes, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

35 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Alkermes Investigational Site
Frankston, Victoria, Australia
Alkermes Investigational Site
Noble Park, Victoria, Australia
Alkermes Investigational Site
Richmond, Victoria, Australia

Puerto Rico

Alkermes Investigational Site
San Juan, Puerto Rico
Alkermes Investigational Site
San Juan, Puerto Rico

United States

Alkermes Investigational Site
Tucson, Arizona, United States
Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Los Alamitos, California, United States
Alkermes Investigational Site
Oceanside, California, United States
Alkermes Investigational Site
Pico Rivera, California, United States
Alkermes Investigational Site
Redlands, California, United States
Alkermes Investigational Site
Santa Ana, California, United States
Alkermes Investigational Site
Sherman Oaks, California, United States
Alkermes Investigational Site
Temecula, California, United States
Alkermes Investigative Site
Upland, California, United States
Alkermes Investigational Site
Hollywood, Florida, United States
Alkermes Investigational Site
Jacksonville, Florida, United States
Alkermes Investigational Site
Lauderhill, Florida, United States
Alkermes Investigational Site
Orlando, Florida, United States
Alkermes Investigative Site
Palm Bay, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Decatur, Georgia, United States
Alkermes Investigational Site
Pikesville, Maryland, United States
Alkermes Investigational Site
O'Fallon, Missouri, United States
Alkermes Investigational Site
Jamaica, New York, United States
Alkermes Investigational Site
Mount Kisco, New York, United States
Alkermes Investigational Site
Canton, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States
Alkermes Investigational Site
Allentown, Pennsylvania, United States
Alkermes Investigational Site
Memphis, Tennessee, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
DeSoto, Texas, United States
Alkermes Investigational Site
Woodstock, Vermont, United States
Alkermes Investigative Site
Bellevue, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ALKS 5461ALKS 5461 Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 12 Jun 2017
Primary completion: 26 Feb 2020
Completion: 5 Mar 2020
Last update posted: 8 Apr 2021
Registered enrollment: 278
Registry id: NCT03188185

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.