A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

Phase 3

Completed

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

• Registration Number: NCT02085135
• Lead Sponsor: Alkermes, Inc.

Brief Summary

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-12
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Disposition First Submitted: 2016-01-06
• Disposition First Submitted QC: 2016-01-06
• Disposition First Posted: 2016-02-05
• Results First Submitted: 2019-03-01
• Results First Submitted QC: 2019-03-01
• Results First Posted: 2019-03-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Body mass index of 18-40 kg/m2
• Have a diagnosis of MDD
• Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
• Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
• Have an inadequate response to current antidepressant treatment
• Agree to use an approved method of birth control for the duration of the study
• Additional criteria may apply

Exclusion Criteria

• Currently pregnant or breastfeeding
• History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
• Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
• Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
• Have received electroconvulsive therapy treatment within the last 5 years
• Have attempted suicide within the past 2 years
• Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
• Have had a significant blood loss or blood donation with 60 days of screening
• Additional criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Titration Schedule 1	ALKS 5461	-
Titration Schedule 2	ALKS 5461	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events (AEs)	8 weeks

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇨🇦 Halifax, Nova Scotia, Canada