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

August 2, 2019 updated by: Alkermes, Inc.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Alkermes Investigational Site
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Alkermes Investigational Site
      • Orlando, Florida, United States, 32806
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Alkermes Investigational Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Alkermes Investigational Site
    • New York
      • Staten Island, New York, United States, 10305
        • Alkermes Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Alkermes Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Titration Schedule 1
Drug: ALKS 5461
Sublingual tablet taken once daily
Experimental: Titration Schedule 2
Drug: ALKS 5461
Sublingual tablet taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With Adverse Events (AEs)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK5461-210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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