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

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ClinicalTrials.gov Identifier: NCT02158533
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the efficacy and safety of ALKS 5461.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: High Dose ALKS 5461 Drug: Low Dose ALKS 5461 Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : May 2014
Primary Completion Date : December 2015
Study Completion Date : December 2015
Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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): 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
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 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