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

NCT03188185 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ALK5461-217
• Study Type: interventional
• Target: 278
• Locations: 3 countries
• Sites: 35

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Alkermes; Major Depressive Disorder; Treatment Refractory MDD; ALKS 5461

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Montgomery Asberg Depression Rating Scale (MADRS) Response Rate

  Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2

• Montgomery Asberg Depression Rating Scale (MADRS) Remission Rate

  5 weeks for Stage 1, 6 weeks for Stage 2

Study Arms (2)

ALKS 5461

EXPERIMENTAL

Sublingual tablets

Drug: ALKS 5461

ALKS 5461 Placebo

PLACEBO COMPARATOR

Sublingual tablets

Drug: ALKS 5461 Placebo

Interventions

ALKS 5461 DRUG

Samidorphan + buprenorphine, administered sublingually

ALKS 5461

ALKS 5461 Placebo DRUG

Placebo tablet, administered sublingually

ALKS 5461 Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (35)

Alkermes Investigational Site

Tucson, Arizona, 85712, United States

Location

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Los Alamitos, California, 90720, United States

Location

Alkermes Investigational Site

Oceanside, California, 92056, United States

Location

Alkermes Investigational Site

Pico Rivera, California, 90660, United States

Location

Alkermes Investigational Site

Redlands, California, 92374, United States

Location

Alkermes Investigational Site

Santa Ana, California, 92705, United States

Location

Alkermes Investigational Site

Sherman Oaks, California, 91403, United States

Location

Alkermes Investigational Site

Temecula, California, 92591, United States

Location

Alkermes Investigative Site

Upland, California, 91786, United States

Location

Alkermes Investigational Site

Hollywood, Florida, 33024, United States

Location

Alkermes Investigational Site

Jacksonville, Florida, 32256, United States

Location

Alkermes Investigational Site

Lauderhill, Florida, 33319, United States

Location

Alkermes Investigational Site

Orlando, Florida, 32801, United States

Location

Alkermes Investigative Site

Palm Bay, Florida, 32905, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30341, United States

Location

Alkermes Investigational Site

Decatur, Georgia, 30030, United States

Location

Alkermes Investigational Site

Pikesville, Maryland, 21208, United States

Location

Alkermes Investigational Site

O'Fallon, Missouri, 63368, United States

Location

Alkermes Investigational Site

Jamaica, New York, 11432, United States

Location

Alkermes Investigational Site

Mount Kisco, New York, 10549, United States

Location

Alkermes Investigational Site

Canton, Ohio, 44720, United States

Location

Alkermes Investigational Site

Cincinnati, Ohio, 45215, United States

Location

Alkermes Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Alkermes Investigational Site

Allentown, Pennsylvania, 18104, United States

Location

Alkermes Investigational Site

Memphis, Tennessee, 38119, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75390, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Alkermes Investigational Site

Woodstock, Vermont, 05091, United States

Location

Alkermes Investigative Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

Frankston, Victoria, 3199, Australia

Location

Alkermes Investigational Site

Noble Park, Victoria, 3174, Australia

Location

Alkermes Investigational Site

Richmond, Victoria, 3121, Australia

Location

Alkermes Investigational Site

San Juan, 00918, Puerto Rico

Location

Alkermes Investigational Site

San Juan, 00926-3160, Puerto Rico

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

ALKS 5461

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Eva Stroynowski
• Organization: Alkermes

eva.stroynowski@alkermes.com

781-609-7000

Study Officials

• Sanjeev Pathak, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 15, 2017
• Study Start: June 12, 2017
• Primary Completion: February 26, 2020
• Study Completion: March 5, 2020
• Last Updated: April 8, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-03

Locations

AU (3); US (30); PR (2)