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A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT02158533
First received: June 5, 2014
Last updated: February 3, 2016
Last verified: February 2016
  Purpose
This study will evaluate the efficacy and safety of ALKS 5461.

Condition Intervention Phase
Major Depressive Disorder
Drug: High Dose ALKS 5461
Drug: Low Dose ALKS 5461
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)

Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 11 weeks ]

Secondary Outcome Measures:
  • Response during randomized treatment [ Time Frame: 11 weeks ]
    Based on pre-specified decrease of MADRS total score

  • Remission during randomized treatment [ Time Frame: 11 weeks ]
    Based on pre-specified MADRS total score

  • Safety and tolerability will be assessed by incidence of adverse events (AEs) [ Time Frame: 12 weeks ]

Enrollment: 385
Study Start Date: May 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose Drug: High Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Name: ALKS 5461
Experimental: Low Dose Drug: Low Dose ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other Name: ALKS 5461
Placebo Comparator: Placebo Drug: Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

  Eligibility

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

Inclusion Criteria:

  • Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
  • Agree to use an acceptable method of contraception for the duration of the study
  • Have a Major Depressive Disorder (MDD) primary diagnosis
  • Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
  • Additional criteria may apply

Exclusion Criteria:

  • 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 one course of electroconvulsive treatment during lifetime
  • Have attempted suicide within the past 2 years
  • Have a positive test for drugs of abuse
  • Are pregnant, planning to become pregnant, or breastfeeding
  • 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 60 days
  • Additional criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02158533

  Show 49 Study Locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Sanjeev Pathak, MD Alkermes, Inc.
  More Information

Additional Information:
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02158533     History of Changes
Other Study ID Numbers: ALK5461-205
Study First Received: June 5, 2014
Last Updated: February 3, 2016

Keywords provided by Alkermes, Inc.:
Major Depressive Disorder
Depression
Alkermes
ALKS 5461
Samidorphan

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 27, 2017