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

Phase 3TerminatedNCT03610048

Alkermes, Inc.175 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

Refractory Major Depressive Disorder

Interventions

ALKS 5461DRUG

samidorphan + buprenorphine administered sublingually

Eligibility

Sex: ALLMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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

Locations (34)

Outcomes

Primary Outcomes

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

Number and percentage of subjects experiencing TEAEs

Time frame: Up to 68 weeks

Data from ClinicalTrials.gov

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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 Investigational Site

Hollywood, Florida, United States

...and 24 more locations