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

Phase 3

Terminated

• Conditions: Refractory Major Depressive Disorder
• Interventions: Drug: ALKS 5461

• Registration Number: NCT03610048
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-01
• Study Start: 2018-08-09
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Results First Submitted: 2021-05-01
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Results First Posted: 2021-07-16
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALKS 5461	ALKS 5461	Sublingual tablets

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	Up to 68 weeks	Number and percentage of subjects experiencing TEAEs

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇵🇷 San Juan, Puerto Rico