A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

A Phase 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: ALKS 5461; Drug: ALKS 5461 Placebo

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Alkermes Investigational Site
    • Noble Park, Victoria, Australia, 3174
      • Alkermes Investigational Site
    • Richmond, Victoria, Australia, 3121
      • Alkermes Investigational Site
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Alkermes Investigational Site
  • San Juan, Puerto Rico, 00926-3160
    • Alkermes Investigational Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Alkermes Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Alkermes Investigational Site
  • California
    • 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 Investigational Site
    • Upland, California, United States, 91786
      • Alkermes Investigative Site
  • Florida
    • 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 Investigational Site
    • Palm Bay, Florida, United States, 32905
      • Alkermes Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Alkermes Investigational Site
    • Decatur, Georgia, United States, 30030
      • Alkermes Investigational Site
  • Maryland
    • Pikesville, Maryland, United States, 21208
      • Alkermes Investigational Site
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Alkermes Investigational Site
  • New York
    • Jamaica, New York, United States, 11432
      • Alkermes Investigational Site
    • Mount Kisco, New York, United States, 10549
      • Alkermes Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44720
      • Alkermes Investigational Site
    • Cincinnati, Ohio, United States, 45215
      • Alkermes Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Alkermes Investigational Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Alkermes Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Alkermes Investigational Site
  • Texas
    • Dallas, Texas, United States, 75390
      • Alkermes Investigational Site
    • DeSoto, Texas, United States, 75115
      • Alkermes Investigational Site
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Alkermes Investigational Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Alkermes Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores	The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (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.	Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery Asberg Depression Rating Scale (MADRS) Response Rate	The percentage of subjects demonstrating a MADRS-10 treatment response, defined as a >/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (MDD) symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).	Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2
Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate	The percentage of subjects achieving remission, defined as a subject with a score </= 10 at the end of the efficacy period (Week 5 for Stage 1, Week 6 for Stage 2). The MADRS-10 scale is a measure of the severity of Major Depressive Disorder (MDD) symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).the end of the efficacy period.	5 weeks for Stage 1, 6 weeks for Stage 2

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Major Depressive Disorder; Alkermes; ALKS 5461; Treatment Refractory MDD
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Alcohol Deterrents; Buprenorphine; Naltrexone
• Other Study ID Numbers: ALK5461-217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No