A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

NCT02158546 | Completed Phase 3 Results

• 1 other identifier: ALK5461-206
• Study Type: interventional
• Target: 447
• Locations: 2 countries
• Sites: 58

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Depression; Alkermes; ALKS 5461; Samidorphan

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

  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.

  Baseline and week 6

Secondary Outcomes (3)

• Proportion of Patients Who Exhibited Treatment Response (MADRS-10)

  6 weeks

• Remission Rate

  6 weeks

• Number of Subjects With Adverse Events (AEs)

  6 weeks

Study Arms (2)

ALKS 5461

EXPERIMENTAL

Drug: ALKS 5461

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALKS 5461 DRUG

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

ALKS 5461

Placebo DRUG

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

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (58)

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Bellflower, California, 90706, United States

Location

Alkermes Investigational Site

Beverly Hills, California, 90210, United States

Location

Alkermes Investigational Site

Glendale, California, 91206, United States

Location

Alkermes Investigational Site

Los Alamitos, California, 90720, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

Redlands, California, 92374, United States

Location

Alkermes Investigational Site

Temecula, California, 92591, United States

Location

Alkermes Investigational Site

Washington D.C., District of Columbia, 20016, United States

Location

Alkermes Investigational Site

Hallandale, Florida, 33009, United States

Location

Alkermes Investigational Site

Hialeah, Florida, 33016, United States

Location

Alkermes Investigational Site

Jacksonville, Florida, 32256, United States

Location

Alkermes Investigational Site

Leesburg, Florida, 34748, United States

Location

Alkermes Investigational Site

Maitland, Florida, 32751, United States

Location

Alkermes Investigational Site

Tampa, Florida, 33613, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30331, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60634, United States

Location

Alkermes Investigational Site

Oak Brook, Illinois, 60523, United States

Location

Alkermes Investigational Site

Vernon Hills, Illinois, 60061, United States

Location

Alkermes Investigational Site

Indianapolis, Indiana, 46260, United States

Location

Alkermes Investigational Site

Lafayette, Indiana, 47905, United States

Location

Alkermes Investigational Site

Edgewood, Kentucky, 41017, United States

Location

Alkermes Investigational

Washington DC, Maryland, 20016, United States

Location

Alkermes Investigational Site

Brockton, Massachusetts, 02301, United States

Location

Alkermes Investigational Site

Watertown, Massachusetts, 02472, United States

Location

Alkermes Investigational Site

Kansas City, Missouri, 64114, United States

Location

Alkermes Investigational Site

O'Fallon, Missouri, 63368, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63109, United States

Location

Alkermes Investigational Site

Cherry Hill, New Jersey, 08002, United States

Location

Alkermes Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

Alkermes Investigational Site

Jamaica, New York, 11432, United States

Location

Alkermes Investigational Site

New York, New York, 10023, United States

Location

Alkermes Investigational Site

Staten Island, New York, 10312, United States

Location

Alkermes Investigational Site

Charlotte, North Carolina, 28204, United States

Location

Alkermes Investigational Site

Beachwood, Ohio, 44122, United States

Location

Alkermes Investigational Site

Cincinnati, Ohio, 45215, United States

Location

Alkermes Investigational Site

Cincinnati, Ohio, 45227, United States

Location

Alkermes Investigational Site

Mason, Ohio, 45040, United States

Location

Alkermes Investigational Site

Middleburg Heights, Ohio, 44130, United States

Location

Alkermes Investigational Site

Portland, Oregon, 97210, United States

Location

Alkermes Investigational Site

Salem, Oregon, 97301, United States

Location

Alkermes Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Alkermes Investigational Site

Charleston, South Carolina, 29407, United States

Location

Alkermes Investigational Site

Memphis, Tennessee, 38119, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75231, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75309, United States

Location

Alkermes Investigational Site

Houston, Texas, 77098, United States

Location

Alkermes Investigational Site

Sugar Land, Texas, 77478, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

Waukesha, Wisconsin, 53188, United States

Location

Alkermes Investigational Site

Burgas, 8001, Bulgaria

Location

Alkermes Investigational Site

Kazanlak, 6100, Bulgaria

Location

Alkermes Investigational Site

Sofia, 1113, Bulgaria

Location

Alkermes Investigational Site

Sofia, 1431, Bulgaria

Location

Alkermes Investigational Site

Sofia, 1632, Bulgaria

Location

Alkermes Investigational Site

Varna, 9020, Bulgaria

Location

Alkermes Investigational Site

Veliko Tarnovo, 5000, Bulgaria

Location

Alkermes Investigational Site

Vratsa, 3000, Bulgaria

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

ALKS 5461

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Pre-specified primary population data are shown. Data from one trial site were excluded as pre-specified due to data integrity concerns (18 subjects). Other excluded subjects did not receive randomized study drug.

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
• Restriction Type: OTHER
• 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 5, 2014
• First Posted: June 9, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 25, 2019
• Results First Posted: June 25, 2019

Record last verified: 2019-05

Locations

BU (8); US (50)