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A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

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ClinicalTrials.gov Identifier: NCT02218008
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Single Group 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-5 Study)
Study Start Date : July 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Dose Drug: ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Experimental: Low Dose Drug: ALKS 5461
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Placebo Comparator: Placebo Drug: Placebo
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)




Primary Outcome Measures :
  1. Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2, combined together for the overall estimate of treatment effect) ]
    The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).

  2. Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]
    The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.

  3. Change From Baseline to End of Treatment in the MADRS-10 [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]
    The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]
    The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 5). The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.

  2. Remission Rate [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]
    The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤10 at the end of the efficacy period.

  3. Adverse Events (AEs) [ Time Frame: 5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2) ]


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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:

  • Have a 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 an 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 their 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

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): NCT02218008


  Hide Study Locations
Locations
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United States, Alabama
Alkermes Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Alkermes Investigational Site
Colton, California, United States, 92324
Alkermes Investigational Site
Garden Grove, California, United States, 92845
Alkermes Investigational Site
Los Angeles, California, United States, 90024
Alkermes Investigational Site
Oakland, California, United States, 94612
Alkermes Investigational Site
Oceanside, California, United States, 92056
Alkermes Investigational Site
Pico Rivera, California, United States, 90660
Alkermes Investigational Site
San Gabriel, California, United States, 91776
United States, Colorado
Alkermes Investigational Site
Colorado Springs, Colorado, United States, 80910
United States, Florida
Alkermes Investigational Site
Bradenton, Florida, United States, 34201
Alkermes Investigational Site
Fort Myers, Florida, United States, 33912
Alkermes Investigational Site
Melbourne, Florida, United States, 32901
Alkermes Investigational Site
North Miami, Florida, United States, 33161
Alkermes Investigational Site
Oakland Park, Florida, United States, 33334
Alkermes Investigational Site
Winter Haven, Florida, United States, 33880
United States, Georgia
Alkermes Investigational Site
Smyrna, Georgia, United States, 30080
United States, Illinois
Alkermes Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Mississippi
Alkermes Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Alkermes Investigational Site
Saint Charles, Missouri, United States, 63304
Alkermes Investigational Site
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Alkermes Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
Alkermes Investigational Site
New York, New York, United States, 10168
United States, North Carolina
Alkermes Investigational Site
High Point, North Carolina, United States, 27265
United States, Ohio
Alkermes Investigational Site
Canton, Ohio, United States, 44718
United States, Oregon
Alkermes Investigational Site
Portland, Oregon, United States, 97214
United States, Tennessee
Alkermes Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Alkermes Investigational Site
DeSoto, Texas, United States, 75115
Alkermes Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Utah
Alkermes Investigational Site
Clinton, Utah, United States, 84015
United States, Washington
Alkermes Investigational Site
Bellevue, Washington, United States, 98007
Alkermes Investigational Site
Seattle, Washington, United States, 98104
Alkermes Investigational Site
Spokane, Washington, United States, 99204
Canada
Alkermes Investigational Site
Gatineau, Canada, J8T 8J1
Alkermes Investigational Site
Halifax, Canada, B3S 1M7
Alkermes Investigational Site
Penticton, Canada, V2A 4M4
Alkermes Investigational Site
Quebec, Canada, G3K 2P8
Germany
Alkermes Investigational Site
Berlin, Germany, 10245
Alkermes Investigational Site
Berlin, Germany, 10629
Alkermes Investigational Site
Hannover, Germany, 30159
Alkermes Investigational Site
Oranienburg, Germany, 16515
Alkermes Investigational Site
Schwerin, Germany, 19053
Alkermes Investigational Site
Stralsund, Germany, 18439
Puerto Rico
Alkermes Investigational Site
San Juan, Puerto Rico, 00918
Alkermes Investigational Site
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Sanjeev Pathak, MD Alkermes, Inc.

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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02218008     History of Changes
Other Study ID Numbers: ALK5461-207
First Posted: August 15, 2014    Key Record Dates
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019
Last Verified: March 2019

Keywords provided by Alkermes, Inc.:
Major depressive disorder (MDD)
depression
Alkermes
ALKS 5461
samidorphan

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Buprenorphine
Naltrexone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents