Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 617
• 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, Inc.
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • NoesisPharma
  • 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
    • 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
    • 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
    • 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
      • University of South Florida, Psychiatry and Behavioral Neurosciences
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Atlanta, Georgia, United States, 30005
      • Institute for Advanced 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
    • 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
    • Gaithersburg, Maryland, United States, 20850
      • CBH Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, Inc.
    • South Weymouth, Massachusetts, United States, 02190
      • Coastal Research Associates
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical Trials
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • 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
    • Saint Louis, Missouri, United States, 63141
      • Millennium Psychiatric Associates
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Premier Psychiatric Research Institute, LLC
  • 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
    • Charleston, North Carolina, United States, 29407
      • Carolina Clinical Trials, Inc.
    • 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, 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
      • Keystone Clinical Studies, LLC
  • South Carolina
    • 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
      • Pharmaceutical Research Associates, Inc
    • Salt Lake City, Utah, United States, 84105
      • Psychiatric and Behavioral Solutions
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Psychiatric Alliance of the Blue Ridge, Inc.
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Bothell, Washington, United States, 98011
      • Pacific Institute of Medical Sciences

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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapastinel; Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.	Drug: Rapastinel; Rapastinel pre-filled syringes for IV injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+)	The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement.	Baseline to 52 Weeks
Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS)	The Clinician Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences composed of 23 subjective self-reported and 5 objective observer-reported ratings, each scored from 0 (not at all) to 4 (extremely). Only the 23 subjective items will be collected and analyzed. The sum of each of the 23 subjective items was used for a total score of 0-92. A negative change from Baseline indicates improvement.	Baseline to 52 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): February 3, 2017
• Primary Completion (Actual): December 6, 2018
• Study Completion (Actual): December 6, 2018

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 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-06

Drug and device information, study documents

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