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

• ClinicalTrials.gov Identifier: NCT02158546
• Recruitment Status: Completed
• First Posted: June 9, 2014
• Results First Posted: June 25, 2019
• Last Update Posted: June 25, 2019
• Sponsor: Alkermes, Inc.
• Information provided by (Responsible Party): Alkermes, Inc.

Tracking Information

• First Submitted Date: June 5, 2014
• First Posted Date: June 9, 2014
• Results First Submitted Date: March 1, 2019
• Results First Posted Date: June 25, 2019
• Last Update Posted Date: June 25, 2019
• Study Start Date: May 2014
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 31, 2019)

Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline and week 6 ]

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.

• Original Primary Outcome Measures (submitted: June 5, 2014): Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 10 weeks ]

Current Secondary Outcome Measures (submitted: May 31, 2019)

• Proportion of Patients Who Exhibited Treatment Response (MADRS-10) [ Time Frame: 6 weeks ]
  The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 6).
• Remission Rate [ Time Frame: 6 weeks ]
  The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤ 10 at the end of the efficacy period.
• Number of Subjects With Adverse Events (AEs) [ Time Frame: 6 weeks ]

Original Secondary Outcome Measures (submitted: June 5, 2014)

• Response during randomized treatment [ Time Frame: 10 weeks ]
  Based on pre-specified decrease of MADRS total score
• Remission during randomized treatment [ Time Frame: 10 weeks ]
  Based on pre-specified MADRS total score
• Safety and tolerability will be assessed by number and percentage of subjects with adverse events (AEs) [ Time Frame: 12 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
• Official Title: A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 Study)
• Brief Summary: This study will evaluate the efficacy and safety of ALKS 5461.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• Drug: ALKS 5461
  Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
• Drug: Placebo
  Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Study Arms

• Experimental: ALKS 5461
  Intervention: Drug: ALKS 5461
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 3, 2016): 447
• Original Estimated Enrollment (submitted: June 5, 2014): 670
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, United States

Administrative Information

• NCT Number: NCT02158546
• Other Study ID Numbers: ALK5461-206
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alkermes, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Alkermes, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Sanjeev Pathak, MD; Alkermes, Inc.

• PRS Account: Alkermes, Inc.
• Verification Date: May 2019