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
1 other identifier
interventional
1,304
1 country
137
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2016
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
November 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2019
CompletedResults Posted
Study results publicly available
March 9, 2020
CompletedMarch 9, 2020
February 1, 2020
2.3 years
October 31, 2016
February 21, 2020
February 21, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Time to First Relapse During the Entire Double-Blind Treatment Period
104 Weeks
Study Arms (3)
Rapastinel 450 mg Weekly
EXPERIMENTALRapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
Rapastinel 450 mg Every 2 Weeks
EXPERIMENTALRapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
Placebo
PLACEBO COMPARATORRapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
Interventions
Rapastinel pre-filled syringes for IV injections.
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (137)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
NoesisPharma
Phoenix, Arizona, 85032, United States
University of Arizona Department of Psychiatry
Tucson, Arizona, 85724, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Woodland Research Northwest
Rogers, Arkansas, 72758, United States
California Pharmaceutical Research Institute, Inc
Anaheim, California, 92804, United States
Southern California Research LLC.
Beverly Hills, California, 90036, United States
ATP Clinical Research Inc.
Costa Mesa, California, 92626, United States
ProScience Research Group
Culver City, California, 90230, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Irvine Center for Clinical Research, Inc
Irvine, California, 92614, United States
Synergy Clinical Research Center of Escondido
Lemon Grove, California, 91945, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pacific Research Partners; LLC.
Oakland, California, 94607, United States
Excell Research
Oceanside, California, 92056, United States
NRC Research Institute
Orange, California, 92868, United States
Asclepes Research Centers
Panorama City, California, 91402, United States
Anderson Clinical Research
Redlands, California, 92374, United States
CITrials
Riverside, California, 92506, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
PCSD Feighner Research
San Diego, California, 92108, United States
Artemis Institute for Clinical Research
San Marcos, California, 92078, United States
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
Sherman Oaks, California, 91403, United States
Viking Clinical Research
Temecula, California, 92591, United States
Pacific Clinical Research Medical
Upland, California, 91786, United States
MCB Clinical Research Center
Colorado Springs, Colorado, 80910, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Meridien Research
Bradenton, Florida, 34201, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
MD Clinical
Hallandale, Florida, 33009, United States
Reliable Clinical Research
Hialeah, Florida, 33012, United States
Advanced Research Institute of Miami
Homestead, Florida, 33030, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Meridien Research
Lakeland, Florida, 33805, United States
Innovative Clinical Research, Inc
Lauderhill, Florida, 33319, United States
Innova Clinical Trials Inc.
Miami, Florida, 33145, United States
International Research Associates, LLC
Miami, Florida, 33183, United States
Research Centers of America
Oakland Park, Florida, 33334, United States
Sarkis Clinical Trials
Ocala, Florida, 34474, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807, United States
Millenia Psychiatry & Research, Inc
Orlando, Florida, 32839, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
Tampa, Florida, 33613, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
IRIS Research
Smyrna, Georgia, 30080, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
AMR - Baber Research, Inc.
Naperville, Illinois, 60563, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Phoenix Medical Research
Prairie Village, Kansas, 66208, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629, United States
Louisiana Clinical Research
Shreveport, Louisiana, 71101, United States
J Gary Booker, MD APMC
Shreveport, Louisiana, 71104, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21204, United States
Pharmasite Research, Inc
Baltimore, Maryland, 21208, United States
CBH Health
Rockville, Maryland, 20850, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, 01844, United States
BTC of New Bedford
New Bedford, Massachusetts, 02740, United States
Adams Clinical Trials
Watertown, Massachusetts, 02472, United States
Coastal Research Associates
Weymouth, Massachusetts, 02190, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Millennium Psychiatric Associates
Creve Coeur, Missouri, 63141, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304, United States
Alivation Research
Lincoln, Nebraska, 68526, United States
Altea Research
Las Vegas, Nevada, 89102, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, 03060, United States
Hassman Research Institute, LLC
Berlin, New Jersey, 08009, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Pharmaceutical Research Associates Inc
Marlton, New Jersey, 08053, United States
Global Medical Institute, LLC
Princeton, New Jersey, 08540, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, 87109, United States
SPRI Clinical Trials, Inc
Brooklyn, New York, 11235, United States
Bioscience Research
Mount Kisco, New York, 10549, United States
Manhattan Behavioral Medicine
New York, New York, 10022, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, 10128, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Fieve Clinical Research
New York, New York, 10168, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
New Hope Clinical Research Inc.
Charlotte, North Carolina, 28211, United States
Richard H. Weisler, MD, PA
Raleigh, North Carolina, 27609, United States
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718, United States
Patient Priority Clinical Site, LLC
Cincinnati, Ohio, 45215, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
The Ohio State University Department of Psychiatry
Columbus, Ohio, 43210, United States
Midwest Clinical Research Center LLC
Dayton, Ohio, 45417, United States
Charak Clinical Research Center
Garfield Heights, Ohio, 44125, United States
Lindner Center of Hope
Mason, Ohio, 45040, United States
Professional Psychiatric Services
Mason, Ohio, 45040, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, 73112, United States
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, 73112, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118, United States
Summit Research Network
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Dr. Cherian Verghese
Norristown, Pennsylvania, 20006, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119, United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, 78737, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
BioBehavioral Research of Austin
Austin, Texas, 78759, United States
Houston Clinical Trials, LLC
Bellaire, Texas, 77401, United States
Relaro Medical Trials
Dallas, Texas, 75243, United States
El Campo Clinical Trials
El Campo, Texas, 77347, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
Earle Research
Houston, Texas, 77058, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Family Psychiatry of The Wood
The Woodlands, Texas, 77381, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, 84105, United States
PRA Health Sciences
Salt Lake City, Utah, 84106, United States
Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
Charlottesville, Virginia, 22903, United States
Psychiatric Alliance of the Blue Ridge, Inc
Charlottesville, Virginia, 22903, United States
NorthWest Clinical Research Center
Bellevue, Washington, 98007, United States
Pacific Institute of Medical Sciences
Bothell, Washington, 98011, United States
Eastside Therapeutic Resource
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Jenna Hoogerheyde
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2016
First Posted
November 1, 2016
Study Start
November 13, 2016
Primary Completion
February 22, 2019
Study Completion
February 22, 2019
Last Updated
March 9, 2020
Results First Posted
March 9, 2020
Record last verified: 2020-02