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Trial record 1 of 1 for:    NCT03188185
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A Study of ALKS 5461 for Treatment Refractory 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: NCT03188185
Recruitment Status : Active, not recruiting
First Posted : June 15, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 5461
Sublingual tablets
Drug: ALKS 5461
Samidorphan + buprenorphine, administered sublingually

Placebo Comparator: ALKS 5461 Placebo
Sublingual tablets
Drug: ALKS 5461 Placebo
Placebo tablet, administered sublingually




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

Secondary Outcome Measures :
  1. Average differences in change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores [ Time Frame: 11 weeks ]
  2. Montgomery Asberg Depression Rating Scale (MADRS) response [ Time Frame: 11 weeks ]
    >/= 50% reduction in MADRS score

  3. Montgomery Asberg Depression Rating Scale (MADRS) remission [ Time Frame: 11 weeks ]
    MADRS score </= 10


Other Outcome Measures:
  1. Improvement in emotional resiliency [ Time Frame: 11 weeks ]
    Change from baseline in Connor-Davidson Resilience Scale (CD-RISC-25) scores

  2. Reduction in emotional blunting [ Time Frame: 11 weeks ]
    Change from baseline in Snaith-Hamilton Pleasure Scale (SHAPS) scores

  3. Improvement in pain [ Time Frame: 11 weeks ]
    Change from baseline in Brief Pain Inventory-Short Form (BPI-SF) scores

  4. Safety will be measured by frequency of serious and non-serious adverse events [ Time Frame: 12 weeks ]
  5. Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 weeks ]
  6. Mean change from baseline in Clinical Opiate Withdrawal Scale (COWS) scores [ Time Frame: 12 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
Criteria

Inclusion Criteria:

  • Have a Major Depressive Disorder (MDD) primary diagnosis
  • Have a body mass index (BMI) of 18.0 to </= 40.0 kg/m^2
  • Be willing and able to follow the study procedures and visits as outlined in the protocol (including agreeing not to enroll in any other clinical trials)
  • Have inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
  • Additional criteria may apply

Exclusion Criteria:

  • Has any finding that would compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements
  • Has any other significant medical condition (eg, neurological, psychiatric, or metabolic) or clinical symptom that could unduly risk the subject or affect the interpretation of study data
  • Has any current primary diagnosis other than MDD, where primary diagnosis is defined as the primary source of current distress and functional impairment
  • Has experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
  • Has been hospitalized for MDD within 3 months before screening
  • Has used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days prior to screening
  • Has received electroconvulsive therapy treatment within the last 2 years or within the current MDE or failed a course of electroconvulsive treatment at any time
  • Has a significant risk for suicide
  • Has a positive breath alcohol test at screening
  • Has a positive test for drugs of abuse at screening or visit 2
  • Is pregnant, planning to become pregnant, or is breastfeeding during the study
  • 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): NCT03188185


Locations
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United States, Arizona
Alkermes Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
United States, California
Alkermes Investigational Site
Los Alamitos, California, United States, 90720
Alkermes Investigational Site
Oceanside, California, United States, 92056
Alkermes Investigational Site
Pico Rivera, California, United States, 90660
Alkermes Investigational Site
Redlands, California, United States, 92374
Alkermes Investigational Site
Santa Ana, California, United States, 92705
Alkermes Investigational Site
Sherman Oaks, California, United States, 91403
Alkermes Investigational Site
Temecula, California, United States, 92591
Alkermes Investigative Site
Upland, California, United States, 91786
United States, Florida
Alkermes Investigational Site
Hollywood, Florida, United States, 33024
Alkermes Investigational Site
Jacksonville, Florida, United States, 32256
Alkermes Investigational Site
Lauderhill, Florida, United States, 33319
Alkermes Investigational Site
Orlando, Florida, United States, 32801
Alkermes Investigative Site
Palm Bay, Florida, United States, 32905
United States, Georgia
Alkermes Investigational Site
Atlanta, Georgia, United States, 30341
Alkermes Investigational Site
Decatur, Georgia, United States, 30030
United States, Maryland
Alkermes Investigational Site
Pikesville, Maryland, United States, 21208
United States, Missouri
Alkermes Investigational Site
O'Fallon, Missouri, United States, 63368
United States, New York
Alkermes Investigational Site
Jamaica, New York, United States, 11432
Alkermes Investigational Site
Mount Kisco, New York, United States, 10549
United States, Ohio
Alkermes Investigational Site
Canton, Ohio, United States, 44720
Alkermes Investigational Site
Cincinnati, Ohio, United States, 45215
United States, Oklahoma
Alkermes Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Alkermes Investigational Site
Allentown, Pennsylvania, United States, 18104
United States, Tennessee
Alkermes Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Alkermes Investigational Site
Dallas, Texas, United States, 75390
Alkermes Investigational Site
DeSoto, Texas, United States, 75115
United States, Vermont
Alkermes Investigational Site
Woodstock, Vermont, United States, 05091
United States, Washington
Alkermes Investigative Site
Bellevue, Washington, United States, 98007
Australia, Victoria
Alkermes Investigational Site
Frankston, Victoria, Australia, 3199
Alkermes Investigational Site
Noble Park, Victoria, Australia, 3174
Alkermes Investigational Site
Richmond, Victoria, Australia, 3121
Puerto Rico
Alkermes Investigational Site
San Juan, Puerto Rico, 00918
Alkermes Investigational Site
San Juan, Puerto Rico, 00926-3160
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: NCT03188185    
Other Study ID Numbers: ALK5461-217
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkermes, Inc.:
Alkermes
Major Depressive Disorder
Treatment Refractory MDD
ALKS 5461
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Naltrexone
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents