A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

NCT03610048 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: ALK5461-218
• Study Type: interventional
• Target: 175
• Locations: 3 countries
• Sites: 34

Brief Summary

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.

Conditions

Refractory Major Depressive Disorder

Keywords

Alkermes; Major depressive disorder; Depression; ALKS 5461

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

  Number and percentage of subjects experiencing TEAEs

  Up to 68 weeks

Study Arms (1)

ALKS 5461

EXPERIMENTAL

Sublingual tablets

Drug: ALKS 5461

Interventions

ALKS 5461 DRUG

samidorphan + buprenorphine administered sublingually

ALKS 5461

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed study ALK5461-217
• Be willing to abide by the contraception requirements as outlined in the study protocol
• Be willing and able to follow the study procedures and visits as outlined in the protocol
• Additional criteria may apply

You may not qualify if:

• Pregnant, planning to become pregnant, or breastfeeding
• A positive urine drug test for drugs of abuse
• Poses a current suicide risk
• Additional criteria may apply

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (34)

Alkermes Investigational Site

Tucson, Arizona, 85712, United States

Location

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Los Alamitos, California, 90720, United States

Location

Alkermes Investigational Site

Oceanside, California, 92054, United States

Location

Alkermes Investigational Site

Pico Rivera, California, 90660, United States

Location

Alkermes Investigational Site

Redlands, California, 92374, United States

Location

Alkermes Investigational Site

Santa Ana, California, 92705, United States

Location

Alkermes Investigational Site

Sherman Oaks, California, 91403, United States

Location

Alkermes Investigational Site

Temecula, California, 92591, United States

Location

Alkermes Investigational Site

Hollywood, Florida, 33024, United States

Location

Alkermes Investigational Site

Jacksonville, Florida, 32256, United States

Location

Alkermes Investigational Site

Lauderhill, Florida, 33319, United States

Location

Alkermes Investigational Site

Orlando, Florida, 32801, United States

Location

Alkermes Investigational Site

Palm Bay, Florida, 32905, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30341, United States

Location

Alkermes Investigational Site

Decatur, Georgia, 30030, United States

Location

Alkermes Investigational Site

Pikesville, Maryland, 21208, United States

Location

Alkermes Investigational Site

O'Fallon, Missouri, 63368, United States

Location

Alkermes Investigational Site

Jamaica, New York, 11432, United States

Location

Alkermes Investigational Site

Mount Kisco, New York, 10549, United States

Location

Alkermes Investigational Site

Canton, Ohio, 44718, United States

Location

Alkermes Investigational Site

Cincinnati, Ohio, 45215, United States

Location

Alkermes Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Alkermes Investigational Site

Allentown, Pennsylvania, 18104, United States

Location

Alkermes Investigational Site

Memphis, Tennessee, 38119, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75390, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Alkermes Investigational Site

Woodstock, Vermont, 05091, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

Frankston, Victoria, 3199, Australia

Location

Alkermes Investigational Site

Noble Park, Victoria, 3174, Australia

Location

Alkermes Investigational Site

Richmond, Victoria, 3121, Australia

Location

Alkermes Investigational Site

San Juan, 00918, Puerto Rico

Location

Alkermes Investigational Site

San Juan, 00926, Puerto Rico

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

ALKS 5461

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Director, Corporate and R&D Communications
• Organization: Alkermes

Gretchen.Murphy@alkermes.com

781-609-7000

Study Officials

• Alkermes Medical Director

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 1, 2018
• Study Start: August 9, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 16, 2021
• Results First Posted: July 16, 2021

Record last verified: 2021-06

Locations

PR (2); AU (3); US (29)