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

Alkermes

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: ALKS 5461

Study type

Interventional

Funder types

Industry

Identifiers

ALK5461-210

Details and patient eligibility

About

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

Enrollment

66 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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