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

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

Completed

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigational Site, Halifax, Nova Scotia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS 5461

Drug

Sublingual tablet taken once daily

Primary outcomes

Number of Subjects With Adverse Events (AEs)

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 12, 2014
Registry last updated: Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed