A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

NCT02158533 | Completed Phase 3 Results

• 1 other identifier: ALK5461-205
• Study Type: interventional
• Target: 385
• Locations: 3 countries
• Sites: 49

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 Week 5 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 5 weeks for each stage

Secondary Outcomes (3)

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

  Baseline and 5 weeks for each stage

• Remission Rate

  Baseline and 5 weeks for each stage

• Number of Subjects With Adverse Events (AEs)

  5 weeks for Stage 1 and 6 weeks for Stage 2

Study Arms (3)

High Dose

EXPERIMENTAL

Drug: High Dose ALKS 5461

Low Dose

EXPERIMENTAL

Drug: Low Dose ALKS 5461

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

High Dose ALKS 5461 DRUG

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

Also known as: ALKS 5461

High Dose

Low Dose ALKS 5461 DRUG

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

Also known as: ALKS 5461

Low Dose

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 (49)

Alkermes Investigational Site

Birmingham, Alabama, 35226, United States

Location

Alkermes Investigational Site

Tucson, Arizona, 85712, United States

Location

Alkermes Investigational Site

Carson, California, 90746, United States

Location

Alkermes Investigational Site

National City, California, 91950, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

Sherman Oaks, California, 91403, United States

Location

Alkermes Investigational Site

Torrance, California, 90502, United States

Location

Alkermes Investigational Site

Upland, California, 91786, United States

Location

Alkermes Investigational Site

Hartford, Connecticut, 06106, United States

Location

Alkermes Investigational Site

Norwich, Connecticut, 06360, United States

Location

Alkermes Investigational Site

Coral Springs, Florida, 33067, United States

Location

Alkermes Investigational Site

Gainesville, Florida, 32607, United States

Location

Alkermes Investigational Site

Lauderhill, Florida, 33319, United States

Location

Alkermes Investigational Site

Orlando, Florida, 32801, United States

Location

Alkermes, Investigational Site

Alpharetta, Georgia, 30005, United States

Location

Alkermes Investigational Site

Decatur, Georgia, 30030, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60640, United States

Location

Alkermes Investigational Site

Joliet, Illinois, 60435, United States

Location

Alkermes Investigational Site

Skokie, Illinois, 60076, United States

Location

Alkermes Investigational Site

Newburgh, Indiana, 47630, United States

Location

Alkermes Investigational Site

Valparaiso, Indiana, 46383, United States

Location

Alkermes Investigational Site

Owensboro, Kentucky, 42301, United States

Location

Alkermes Investigational Site

Baltimore, Maryland, 21208, United States

Location

Alkermes Investigational Site

Baltimore, Maryland, 21285, United States

Location

Alkermes Investigational Site

Berlin, New Jersey, 08009, United States

Location

Alkermes Investigational Site

Brooklyn, New York, 11241, United States

Location

Alkermes Investigational Site

Mount Kisco, New York, 10549, United States

Location

Alkermes Investigational Site

New York, New York, 10128, United States

Location

Alkermes Investigational Site

Staten Island, New York, 10305, United States

Location

Alkermes Investigational Site

Canton, Ohio, 44718, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45417, United States

Location

Alkermes Investigational Site

Oklahoma City, Oklahoma, 73103, 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

Media, Pennsylvania, 19063, United States

Location

Alkermes Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Alkermes Investigational Site

Lincoln, Rhode Island, 02865, United States

Location

Alkermes Investigational Site

Austin, Texas, 78731, United States

Location

Alkermes Investigational Site

Houston, Texas, 77081, United States

Location

Alkermes Investigational Site

San Antonio, Texas, 78229, United States

Location

Alkermes Investigational Site

Woodstock, Vermont, 05091, United States

Location

Alkermes Investigational Site

Middleton, Wisconsin, 53562, United States

Location

Alkermes Investigational Site

Brisbane, Queensland, 4000, Australia

Location

Alkermes Investigational Site

Towong, Queensland, 4066, Australia

Location

Alkermes Investigational Site

Frankston, Victoria, 3199, Australia

Location

Alkermes Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Alkermes Investigational Site

Penticton, British Columbia, Canada

Location

Alkermes Investigational Site

Gatineau, Quebec, Canada

Location

Alkermes Investigational Site

Québec, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

ALKS 5461

Condition Hierarchy (Ancestors)

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

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: August 14, 2019
• Results First Posted: March 27, 2019

Record last verified: 2019-08

Locations

CA (3); US (42); AU (4)