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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02085135
Recruitment Status : Completed
First Posted : March 12, 2014
Results First Posted : March 27, 2019
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Alkermes, Inc.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: ALKS 5461 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Study Start Date : February 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Number of Subjects With Adverse Events (AEs) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085135

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United States, Florida
Alkermes Investigational Site
Jacksonville, Florida, United States, 32256
Alkermes Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
Alkermes Investigational Site
Atlanta, Georgia, United States, 30308
United States, Missouri
Alkermes Investigational Site
Saint Charles, Missouri, United States, 63304
United States, New York
Alkermes Investigational Site
Staten Island, New York, United States, 10305
United States, Ohio
Alkermes Investigational Site
Dayton, Ohio, United States, 45417
United States, Pennsylvania
Alkermes Investigational Site
Allentown, Pennsylvania, United States, 18104
United States, Washington
Alkermes Investigational Site
Bellevue, Washington, United States, 98007
Canada, Nova Scotia
Alkermes Investigational Site
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Alkermes, Inc.
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Study Director: Sanjeev Pathak, MD Alkermes, Inc.
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02085135    
Other Study ID Numbers: ALK5461-210
First Posted: March 12, 2014    Key Record Dates
Results First Posted: March 27, 2019
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Alkermes, Inc.:
major depressive disorder
ALKS 5461
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms