A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder

This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Rapastinel; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 429
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Harmonex Neuroscience Research
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • NoesisPharma
  • California
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • Irvine, California, United States, 92614
      • Irvine Center for Clinical Research, Inc
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Panorama City, California, United States, 91402
      • ASCLEPES Research Centers
    • San Marcos, California, United States, 92078
      • Artemis Institute for Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Center
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Hollywood, Florida, United States, 33024
      • Research Centers of America
    • Miami, Florida, United States, 33133
      • Innova Clinical Trials Inc.
    • Orlando, Florida, United States, 32807
      • Combined Research Orlando Phase I-IV
    • Tampa, Florida, United States, 33609
      • Olympian Clinical Research
    • Tampa, Florida, United States, 33613
      • The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
  • Illinois
    • Naperville, Illinois, United States, 60563
      • AMR - Baber Research, Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Louisiana Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Sheppard Pratt Health System
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates - Midwest Research Group
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Healthy Perspectives - Innovative Mental Health Services. PLLC
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute, LLC
    • Princeton, New Jersey, United States, 08540
      • Global Medical Institute, LLC
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience, Inc
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, Inc
    • New York, New York, United States, 10168
      • Fieve Clinical Research
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • New Hope Clinical Research Inc.
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 20006
      • Dr. Cherian Verghese
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Strategies of Memphis, LLC
  • Texas
    • Bellaire, Texas, United States, 77401
      • Houston Clinical Trials, LLC
    • Fort Worth, Texas, United States, 76104
      • North Texas Clinical Trials
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Utah
    • Salt Lake City, Utah, United States, 84105
      • Psychiatric and Behavioral Solutions
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Psychiatric Alliance of the Blue Ridge, Inc.
    • Charlottesville, Virginia, United States, 22903
      • Department of Psychiatry and Neurobehavioral Sciences, University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
• Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
• Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
• If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

• DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

• Lifetime history of meeting DSM-5 criteria for:

  1. Schizophrenia spectrum or other psychotic disorder
  2. Bipolar or related disorder
  3. Major neurocognitive disorder
  4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
  5. Dissociative disorder
  6. Posttraumatic stress disorder
  7. MDD with psychotic features
• Significant suicide risk, as judged by the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.	Drug: Placebo; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
EXPERIMENTAL: Rapastinel 450 mg; Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.	Drug: Rapastinel; Rapastinel pre-filled syringes for weekly IV injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.	Baseline and 3 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in MADRS Total Score	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.	Baseline and Day 8
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.	Baseline and Day 21
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.	Baseline and Day 8

Collaborators and Investigators

• Sponsor: Naurex, Inc, an affiliate of Allergan plc

Publications and helpful links

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2016
• Primary Completion (ACTUAL): October 26, 2018
• Study Completion (ACTUAL): November 21, 2018

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (ESTIMATE): October 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: RAP-MD-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No