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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03188185

Public ClinicalTrials.gov record NCT03188185. 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 2, 2026, 3:25 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 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder

Brief summary

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

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

Study identification

NCT ID
NCT03188185
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alkermes, Inc.
Industry
Enrollment
278 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
Jun 11, 2017
Primary completion
Feb 25, 2020
Completion
Mar 4, 2020
Last update posted
Apr 7, 2021

2017 – 2020

United States locations

U.S. sites
30
U.S. states
15
U.S. cities
30
Facility City State ZIP Site status
Alkermes Investigational Site Tucson Arizona 85712
Alkermes Investigational Site Little Rock Arkansas 72211
Alkermes Investigational Site Los Alamitos California 90720
Alkermes Investigational Site Oceanside California 92056
Alkermes Investigational Site Pico Rivera California 90660
Alkermes Investigational Site Redlands California 92374
Alkermes Investigational Site Santa Ana California 92705
Alkermes Investigational Site Sherman Oaks California 91403
Alkermes Investigational Site Temecula California 92591
Alkermes Investigative Site Upland California 91786
Alkermes Investigational Site Hollywood Florida 33024
Alkermes Investigational Site Jacksonville Florida 32256
Alkermes Investigational Site Lauderhill Florida 33319
Alkermes Investigational Site Orlando Florida 32801
Alkermes Investigative Site Palm Bay Florida 32905
Alkermes Investigational Site Atlanta Georgia 30341
Alkermes Investigational Site Decatur Georgia 30030
Alkermes Investigational Site Pikesville Maryland 21208
Alkermes Investigational Site O'Fallon Missouri 63368
Alkermes Investigational Site Jamaica New York 11432
Alkermes Investigational Site Mount Kisco New York 10549
Alkermes Investigational Site Canton Ohio 44720
Alkermes Investigational Site Cincinnati Ohio 45215
Alkermes Investigational Site Oklahoma City Oklahoma 73112
Alkermes Investigational Site Allentown Pennsylvania 18104
Alkermes Investigational Site Memphis Tennessee 38119
Alkermes Investigational Site Dallas Texas 75390
Alkermes Investigational Site DeSoto Texas 75115
Alkermes Investigational Site Woodstock Vermont 05091
Alkermes Investigative Site Bellevue Washington 98007

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 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03188185, 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 Apr 7, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03188185 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →