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

NCT ID: NCT03610048

Last Updated: 2021-07-16

Study Results

Results available

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View full results

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-09

Study Completion Date

2020-05-01

Brief Summary

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

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Detailed Description

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Conditions

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Refractory Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALKS 5461

Sublingual tablets

Group Type EXPERIMENTAL

ALKS 5461

Intervention Type DRUG

samidorphan + buprenorphine administered sublingually

Interventions

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ALKS 5461

samidorphan + buprenorphine administered sublingually

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alkermes Medical Director

Role: STUDY_DIRECTOR

Alkermes, Inc.

Locations

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Alkermes Investigational Site

Tucson, Arizona, United States

Site Status

Alkermes Investigational Site

Little Rock, Arkansas, United States

Site Status

Alkermes Investigational Site

Los Alamitos, California, United States

Site Status

Alkermes Investigational Site

Oceanside, California, United States

Site Status

Alkermes Investigational Site

Pico Rivera, California, United States

Site Status

Alkermes Investigational Site

Redlands, California, United States

Site Status

Alkermes Investigational Site

Santa Ana, California, United States

Site Status

Alkermes Investigational Site

Sherman Oaks, California, United States

Site Status

Alkermes Investigational Site

Temecula, California, United States

Site Status

Alkermes Investigational Site

Hollywood, Florida, United States

Site Status

Alkermes Investigational Site

Jacksonville, Florida, United States

Site Status

Alkermes Investigational Site

Lauderhill, Florida, United States

Site Status

Alkermes Investigational Site

Orlando, Florida, United States

Site Status

Alkermes Investigational Site

Palm Bay, Florida, United States

Site Status

Alkermes Investigational Site

Atlanta, Georgia, United States

Site Status

Alkermes Investigational Site

Decatur, Georgia, United States

Site Status

Alkermes Investigational Site

Pikesville, Maryland, United States

Site Status

Alkermes Investigational Site

O'Fallon, Missouri, United States

Site Status

Alkermes Investigational Site

Jamaica, New York, United States

Site Status

Alkermes Investigational Site

Mount Kisco, New York, United States

Site Status

Alkermes Investigational Site

Canton, Ohio, United States

Site Status

Alkermes Investigational Site

Cincinnati, Ohio, United States

Site Status

Alkermes Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Alkermes Investigational Site

Allentown, Pennsylvania, United States

Site Status

Alkermes Investigational Site

Memphis, Tennessee, United States

Site Status

Alkermes Investigational Site

Dallas, Texas, United States

Site Status

Alkermes Investigational Site

DeSoto, Texas, United States

Site Status

Alkermes Investigational Site

Woodstock, Vermont, United States

Site Status

Alkermes Investigational Site

Bellevue, Washington, United States

Site Status

Alkermes Investigational Site

Frankston, Victoria, Australia

Site Status

Alkermes Investigational Site

Noble Park, Victoria, Australia

Site Status

Alkermes Investigational Site

Richmond, Victoria, Australia

Site Status

Alkermes Investigational Site

San Juan, , Puerto Rico

Site Status

Alkermes Investigational Site

San Juan, , Puerto Rico

Site Status

Countries

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United States Australia Puerto Rico

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ALK5461-218

Identifier Type: -

Identifier Source: org_study_id

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