A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

NCT02218008 | Completed Phase 3 Results

• 1 other identifier: ALK5461-207
• Study Type: interventional
• Target: 407
• Locations: 4 countries
• Sites: 44

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder (MDD); depression; Alkermes; ALKS 5461; samidorphan

Outcome Measures

Primary Outcomes (3)

• Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)

  The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).

  Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect

• Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)

  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.

  5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)

• Change From Baseline to End of Treatment in the MADRS-10

  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.

  5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)

Secondary Outcomes (3)

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

  5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)

• Remission Rate

  5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)

• Number of Subjects With Adverse Events (AEs)

  5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)

Study Arms (3)

High Dose

EXPERIMENTAL

Drug: ALKS 5461

Low Dose

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)

High Dose; 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 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 an 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 their 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 (44)

Alkermes Investigational Site

Birmingham, Alabama, 35294, United States

Location

Alkermes Investigational Site

Colton, California, 92324, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Location

Alkermes Investigational Site

Los Angeles, California, 90024, United States

Location

Alkermes Investigational Site

Oakland, California, 94612, 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

San Gabriel, California, 91776, United States

Location

Alkermes Investigational Site

Colorado Springs, Colorado, 80910, United States

Location

Alkermes Investigational Site

Bradenton, Florida, 34201, United States

Location

Alkermes Investigational Site

Fort Myers, Florida, 33912, United States

Location

Alkermes Investigational Site

Melbourne, Florida, 32901, United States

Location

Alkermes Investigational Site

North Miami, Florida, 33161, United States

Location

Alkermes Investigational Site

Oakland Park, Florida, 33334, United States

Location

Alkermes Investigational Site

Winter Haven, Florida, 33880, United States

Location

Alkermes Investigational Site

Smyrna, Georgia, 30080, United States

Location

Alkermes Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

Alkermes Investigational Site

Flowood, Mississippi, 39232, United States

Location

Alkermes Investigational Site

Saint Charles, Missouri, 63304, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63141, United States

Location

Alkermes Investigational Site

Princeton, New Jersey, 08540, United States

Location

Alkermes Investigational Site

New York, New York, 10168, United States

Location

Alkermes Investigational Site

High Point, North Carolina, 27265, United States

Location

Alkermes Investigational Site

Canton, Ohio, 44718, United States

Location

Alkermes Investigational Site

Portland, Oregon, 97214, United States

Location

Alkermes Investigational Site

Memphis, Tennessee, 38119, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Alkermes Investigational Site

Wichita Falls, Texas, 76309, United States

Location

Alkermes Investigational Site

Clinton, Utah, 84015, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

Seattle, Washington, 98104, United States

Location

Alkermes Investigational Site

Spokane, Washington, 99204, United States

Location

Alkermes Investigational Site

Gatineau, J8T 8J1, Canada

Location

Alkermes Investigational Site

Halifax, B3S 1M7, Canada

Location

Alkermes Investigational Site

Penticton, V2A 4M4, Canada

Location

Alkermes Investigational Site

Québec, G3K 2P8, Canada

Location

Alkermes Investigational Site

Berlin, 10245, Germany

Location

Alkermes Investigational Site

Berlin, 10629, Germany

Location

Alkermes Investigational Site

Hanover, 30159, Germany

Location

Alkermes Investigational Site

Oranienburg, 16515, Germany

Location

Alkermes Investigational Site

Schwerin, 19053, Germany

Location

Alkermes Investigational Site

Stralsund, 18439, Germany

Location

Alkermes Investigational Site

San Juan, 00918, Puerto Rico

Location

Alkermes Investigational Site

San Juan, 00926, Puerto Rico

Location

Related Links

• Study-specific website

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, Inc.

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: August 14, 2014
• First Posted: August 15, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 14, 2019
• Results First Posted: March 27, 2019

Record last verified: 2019-08

Locations

PR (2); US (32); DE (6); CA (4)