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

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ClinicalTrials.gov Identifier: NCT02951988
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Rapastinel Drug: Placebo-matching Rapastinel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Actual Study Start Date : November 13, 2016
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapastinel 450 mg Weekly
Rapastinel 450 milligrams (mg) intravenous (IV) open label once a week followed by rapastinel 450 mg IV once a week. 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 IV injections.

Experimental: Rapastinel 450 mg Every 2 Weeks
Rapastinel 450 mg IV open label once a week followed by rapastinel 450 mg IV once every 2 weeks. 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 IV injections.

Placebo Comparator: Placebo
Rapastinel 450 mg IV open label once a week followed by placebo-matching rapastinel 450 mg IV once a week. 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-matching Rapastinel
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.




Primary Outcome Measures :
  1. Time to First Relapse during the First 52 Weeks of the Double-Blind Treatment Period [ Time Frame: 52 Weeks ]
    Time in days from randomization to relapse. The primary efficacy analysis will compare the time to relapse between placebo and rapastinel treatment groups using the log-rank test.


Secondary Outcome Measures :
  1. Time to First Relapse during the Entire Double-Blind Treatment Period [ Time Frame: 104 Weeks ]
    Time in days from randomization to relapse. The secondary efficacy analysis will compare the time to relapse between placebo and rapastinel treatment groups using the log-rank test.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951988


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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
United States, Arizona
NoesisPharma
Phoenix, Arizona, United States, 85032
University of Arizona Department of Psychiatry
Tucson, Arizona, United States, 85724
United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
United States, California
California Pharmaceutical Research Institute, Inc
Anaheim, California, United States, 92804
Southern California Research LLC.
Beverly Hills, California, United States, 90036
ATP Clinical Research Inc.
Costa Mesa, California, United States, 92626
ProScience Research Group
Culver City, California, United States, 90230
Pharmacology Research Institute
Encino, California, United States, 91316
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
Sun Valley Research Center
Imperial, California, United States, 92251
Irvine Center for Clinical Research, Inc
Irvine, California, United States, 92614
Synergy Clinical Research Center of Escondido
Lemon Grove, California, United States, 91945
Synergy San Diego
Lemon Grove, California, United States, 91945
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pacific Research Partners; LLC.
Oakland, California, United States, 94607
Excell Research
Oceanside, California, United States, 92056
NRC Research Institute
Orange, California, United States, 92868
Asclepes Research Centers
Panorama City, California, United States, 91402
Anderson Clinical Research
Redlands, California, United States, 92374
CITrials
Riverside, California, United States, 92506
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
PCSD Feighner Research
San Diego, California, United States, 92108
Artemis Institute for Clinical Research
San Marcos, California, United States, 92078
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
Sherman Oaks, California, United States, 91403
Viking Clinical Research
Temecula, California, United States, 92591
Pacific Clinical Research Medical
Upland, California, United States, 91786
United States, Colorado
MCB Clinical Research Center
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34201
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
MD Clinical
Hallandale Beach, Florida, United States, 33009
Reliable Clinical Research
Hialeah, Florida, United States, 33012
Advanced Research Institute of Miami
Homestead, Florida, United States, 33030
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States, 32256
Meridien Research
Lakeland, Florida, United States, 33805
Innovative Clinical Research, Inc
Lauderhill, Florida, United States, 33319
Innova Clinical Trials Inc.
Miami, Florida, United States, 33145
International Research Associates, LLC
Miami, Florida, United States, 33183
Research Centers of America
Oakland Park, Florida, United States, 33334
Sarkis Clinical Trials
Ocala, Florida, United States, 34474
Medical Research Group of Central Florida
Orange City, Florida, United States, 32763
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States, 32801
Combined Research Orlando Phase I-IV
Orlando, Florida, United States, 32807
Millenia Psychiatry & Research, Inc
Orlando, Florida, United States, 32839
Olympian Clinical Research
Tampa, Florida, United States, 33609
The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
Tampa, Florida, United States, 33613
United States, Georgia
Institute for Advanced Medical Research
Alpharetta, Georgia, United States, 30005
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
iResearch Atlanta, LLC
Decatur, Georgia, United States, 30030
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
IRIS Research
Smyrna, Georgia, United States, 30080
United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States, 60169
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
AMR - Baber Research, Inc.
Naperville, Illinois, United States, 60563
United States, Kansas
Psychiatric Associates
Overland Park, Kansas, United States, 66211
Phoenix Medical Research
Prairie Village, Kansas, United States, 66208
Heartland Research Associates
Wichita, Kansas, United States, 67207
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Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
Louisiana Clinical Research
Shreveport, Louisiana, United States, 71101
J Gary Booker, MD APMC
Shreveport, Louisiana, United States, 71104
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204
Pharmasite Research, Inc
Baltimore, Maryland, United States, 21208
CBH Health
Rockville, Maryland, United States, 20850
United States, Massachusetts
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States, 01844
BTC of New Bedford
New Bedford, Massachusetts, United States, 02740
Adams Clinical Trials
Watertown, Massachusetts, United States, 02472
Coastal Research Associates
Weymouth, Massachusetts, United States, 02190
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
Millennium Psychiatric Associates
Creve Coeur, Missouri, United States, 63141
Psychiatric Care and Research Center
O'Fallon, Missouri, United States, 63368
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States, 63304
United States, Nebraska
Alivation Research
Lincoln, Nebraska, United States, 68526
United States, Nevada
Altea Research
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Hassman Research Institute, LLC
Berlin, New Jersey, United States, 08009
Center for Emotional Fitness
Cherry Hill, New Jersey, United States, 08002
Pharmaceutical Research Associates Inc
Marlton, New Jersey, United States, 08053
Global Medical Institute, LLC
Princeton, New Jersey, United States, 08540
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, New Mexico
Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, United States, 87109
United States, New York
SPRI Clinical Trials, Inc
Brooklyn, New York, United States, 11235
Bioscience Research
Mount Kisco, New York, United States, 10549
Manhattan Behavioral Medicine
New York, New York, United States, 10022
Eastside Comprehensive Medical Center, LLC
New York, New York, United States, 10128
The Medical Research Network, LLC
New York, New York, United States, 10128
Fieve Clinical Research
New York, New York, United States, 10168
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, North Carolina
New Hope Clinical Research Inc.
Charlotte, North Carolina, United States, 28211
Richard H. Weisler, MD, PA
Raleigh, North Carolina, United States, 27609
United States, Ohio
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, United States, 44718
Patient Priority Clinical Site, LLC
Cincinnati, Ohio, United States, 45215
University of Cincinnati
Cincinnati, Ohio, United States, 45219
The Ohio State University Department of Psychiatry
Columbus, Ohio, United States, 43210
Midwest Clinical Research Center LLC
Dayton, Ohio, United States, 45417
Charak Clinical Research Center
Garfield Heights, Ohio, United States, 44125
Lindner Center of Hope
Mason, Ohio, United States, 45040
Professional Psychiatric Services
Mason, Ohio, United States, 45040
United States, Oklahoma
IPS Research
Oklahoma City, Oklahoma, United States, 73103
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, United States, 73112
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, United States, 73112
Paradigm Research Professionals
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Dr. Cherian Verghese
Norristown, Pennsylvania, United States, 20006
United States, South Carolina
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States, 29407
Coastal Carolina Research Center, Inc.
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States, 38119
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States, 38119
United States, Texas
Donald J. Garcia, Jr., MD, PA
Austin, Texas, United States, 78737
Community Clinical Research, Inc.
Austin, Texas, United States, 78754
BioBehavioral Research of Austin
Austin, Texas, United States, 78759
Houston Clinical Trials, LLC
Bellaire, Texas, United States, 77401
Relaro Medical Trials
Dallas, Texas, United States, 75243
El Campo Clinical Trials
El Campo, Texas, United States, 77347
North Texas Clinical Trials
Fort Worth, Texas, United States, 76104
Earle Research
Houston, Texas, United States, 77058
Red Oak Psychiatry Associates, PA
Houston, Texas, United States, 77090
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Family Psychiatry of The Wood
The Woodlands, Texas, United States, 77381
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
United States, Utah
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, United States, 84105
PRA Health Sciences
Salt Lake City, Utah, United States, 84106
United States, Virginia
Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
Charlottesville, Virginia, United States, 22903
Psychiatric Alliance of the Blue Ridge, Inc
Charlottesville, Virginia, United States, 22903
United States, Washington
NorthWest Clinical Research Center
Bellevue, Washington, United States, 98007
Pacific Institute of Medical Sciences
Bothell, Washington, United States, 98011
Eastside Therapeutic Resource
Everett, Washington, United States, 98201
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
Study Director: Robert Hayes, PhD Allergan

Additional Information:
Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02951988     History of Changes
Other Study ID Numbers: RAP-MD-04
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms