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A Long-Term Safety Study of ALKS 5461

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: NCT02141399
Recruitment Status : Completed
First Posted : May 19, 2014
Results First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Study Description
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Brief Summary:
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1485 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)
Actual Study Start Date : May 2014
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ALKS 5461 Drug: ALKS 5461
Sublingual tablet, taken daily


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 56 weeks ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Agree to use an approved method of contraception for the duration of the study
  • Have the potential to safely benefit from the administration of ALKS 5461
  • Have a diagnosis of major depressive disorder (MDD)
  • Additional criteria may apply

Exclusion Criteria:

  • Have a positive test for drugs of abuse
  • Currently pregnant or breastfeeding
  • Have a current primary Axis-I disorder other than MDD
  • Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
  • Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime
  • 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 within the past 60 days
  • Additional criteria may apply
Contacts and Locations
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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): NCT02141399


Locations
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Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Sanjeev Pathak, MD Alkermes, Inc.
  Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:
Study Protocol  [PDF] March 3, 2016
Statistical Analysis Plan  [PDF] September 15, 2017

More Information
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02141399    
Other Study ID Numbers: ALK5461-208
First Posted: May 19, 2014    Key Record Dates
Results First Posted: December 14, 2018
Last Update Posted: December 14, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms