A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1304
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Dothan, Alabama, United States, 36303
      • Harmonex Neuroscience Research
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • NoesisPharma
    • Tucson, Arizona, United States, 85724
      • University of Arizona Department of Psychiatry
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • California
    • Anaheim, California, United States, 92804
      • California Pharmaceutical Research Institute, Inc
    • Beverly Hills, California, United States, 90036
      • Southern California Research LLC.
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research Inc.
    • Culver City, California, United States, 90230
      • ProScience Research Group
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network, LLC
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • Irvine, California, United States, 92614
      • Irvine Center for Clinical Research, Inc
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Lemon Grove, California, United States, 91945
      • Synergy Clinical Research Center Of Escondido
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Oakland, California, United States, 94607
      • Pacific Research Partners; LLC.
    • Oceanside, California, United States, 92056
      • Excell Research
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Panorama City, California, United States, 91402
      • ASCLEPES Research Centers
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • Riverside, California, United States, 92506
      • CiTrials
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92108
      • PCSD Feighner Research
    • San Marcos, California, United States, 92078
      • Artemis Institute for Clinical Research
    • Sherman Oaks, California, United States, 91403
      • Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
    • Temecula, California, United States, 92591
      • Viking Clinical Research
    • Upland, California, United States, 91786
      • Pacific Clinical Research Medical
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Center
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Comprehensive Psychiatric Care
  • Florida
    • Bradenton, Florida, United States, 34201
      • Meridien Research
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Hialeah, Florida, United States, 33012
      • Reliable Clinical Research
    • Homestead, Florida, United States, 33030
      • Advanced Research Institute of Miami
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc
    • Lakeland, Florida, United States, 33805
      • Meridien Research
    • Lauderhill, Florida, United States, 33319
      • Innovative Clinical Research, Inc
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC
    • Miami, Florida, United States, 33145
      • Innova Clinical Trials Inc.
    • Oakland Park, Florida, United States, 33334
      • Research Centers of America
    • Ocala, Florida, United States, 34474
      • Sarkis Clinical Trials
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc
    • Orlando, Florida, United States, 32807
      • Combined Research Orlando Phase I-IV
    • Orlando, Florida, United States, 32839
      • Millenia Psychiatry & Research, Inc
    • 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
    • Alpharetta, Georgia, United States, 30005
      • Institute for Advanced Medical Research
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
    • Smyrna, Georgia, United States, 30080
      • IRIS Research
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
    • Hoffman Estates, Illinois, United States, 60169
      • Alexian Brothers Center for Psychiatric Research
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
    • Naperville, Illinois, United States, 60563
      • AMR - Baber Research, Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
    • Prairie Village, Kansas, United States, 66208
      • Phoenix Medical Research
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials
    • Shreveport, Louisiana, United States, 71101
      • Louisiana Clinical Research
    • Shreveport, Louisiana, United States, 71104
      • J Gary Booker, MD APMC
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Sheppard Pratt Health System
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc
    • Rockville, Maryland, United States, 20850
      • CBH Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, Inc.
    • New Bedford, Massachusetts, United States, 02740
      • BTC of New Bedford
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical Trials
    • Weymouth, Massachusetts, United States, 02190
      • Coastal Research Associates
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Millennium Psychiatric Associates
    • 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
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea 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
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Marlton, New Jersey, United States, 08053
      • Pharmaceutical Research Associates Inc
    • 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
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • New York, New York, United States, 10022
      • Manhattan Behavioral Medicine
    • New York, New York, United States, 10168
      • Fieve Clinical Research
    • New York, New York, United States, 10128
      • Eastside Comprehensive Medical Center, LLC
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • New Hope Clinical Research Inc.
    • Raleigh, North Carolina, United States, 27609
      • Richard H. Weisler, MD, PA
  • Ohio
    • Canton, Ohio, United States, 44718
      • Neuro-Behavioral Clinical Research, Inc
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Site, LLC
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Department of Psychiatry
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center LLC
    • Garfield Heights, Ohio, United States, 44125
      • Charak Clinical Research Center
    • Mason, Ohio, United States, 45040
      • Professional Psychiatric Services
    • Mason, Ohio, United States, 45040
      • Lindner Center of Hope
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Paradigm Research Professionals
    • Oklahoma City, Oklahoma, United States, 73112
      • Red River Medical Research Center, LLC
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research, Inc
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Norristown, Pennsylvania, United States, 20006
      • Dr. Cherian Verghese
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Carolina Clinical Trials, Inc.
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center, Inc.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Research Strategies of Memphis, LLC
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • Austin, Texas, United States, 78737
      • Donald J. Garcia, Jr., MD, PA
    • Austin, Texas, United States, 78759
      • BioBehavioral Research of Austin
    • Bellaire, Texas, United States, 77401
      • Houston Clinical Trials, LLC
    • Dallas, Texas, United States, 75243
      • Relaro Medical Trials
    • El Campo, Texas, United States, 77347
      • El Campo Clinical Trials
    • Fort Worth, Texas, United States, 76104
      • North Texas Clinical Trials
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates, PA
    • Houston, Texas, United States, 77058
      • Earle Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
    • The Woodlands, Texas, United States, 77381
      • Family Psychiatry of The Wood
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • PRA Health Sciences
    • 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
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Bothell, Washington, United States, 98011
      • Pacific Institute of Medical Sciences
    • Everett, Washington, United States, 98201
      • Eastside Therapeutic Resource

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 Screening
• 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 Screening
• Lifetime history of meeting DSM-5 criteria for:
• Schizophrenia spectrum or other psychotic disorder
• Bipolar or related disorder
• Major neurocognitive disorder
• 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
• Dissociative disorder
• Posttraumatic stress disorder
• 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 Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapastinel 450 mg Weekly; Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.	Drug: Rapastinel; Rapastinel pre-filled syringes for IV injections.
Experimental: Rapastinel 450 mg Every 2 Weeks; Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.	Drug: Rapastinel; Rapastinel pre-filled syringes for IV injections.
Placebo Comparator: Placebo; Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.	Drug: Placebo-matching Rapastinel; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period	The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.	52 Weeks
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales	On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"	104 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Relapse During the Entire Double-Blind Treatment Period	The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.	104 Weeks

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 13, 2016
• Primary Completion (Actual): February 22, 2019
• Study Completion (Actual): February 22, 2019

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

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-04

Drug and device information, study documents

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