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

Alkermes

Status and phase: Terminated; Phase 3

Conditions: Refractory Major Depressive Disorder

Treatments: Drug: ALKS 5461

Study type: Interventional

Funder types: Industry

Identifiers

NCT03610048

ALK5461-218

Details and patient eligibility

About

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

Enrollment: 175 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

ALKS 5461

Experimental group

Description:

Sublingual tablets

Treatment:

Drug: ALKS 5461