A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)
NCT ID: NCT02943564
Last Updated: 2019-12-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
658 participants
INTERVENTIONAL
2016-11-01
2018-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rapastinel 225 mg
Rapastinel 225 milligram (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.
Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.
Rapastinel 450 mg
Rapastinel 450 mg 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.
Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.
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.
Placebo
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Interventions
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Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.
Placebo
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Naurex, Inc, an affiliate of Allergan plc
INDUSTRY
Responsible Party
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Principal Investigators
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Jenna Hoogerheyde
Role: STUDY_DIRECTOR
Allergan
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona Department of Psychiatry
Tucson, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
California Pharmaceutical Research Institute, Inc
Anaheim, California, United States
ProScience Research Group
Culver City, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Synergy Clinical Research Center of Escondido
Lemon Grove, California, United States
Pacific Research Partners; LLC.
Oakland, California, United States
CITrials
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
PCSD Feighner Research
San Diego, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Reliable Clinical Research
Hialeah, Florida, United States
Advanced Research Institute of Miami
Homestead, Florida, United States
Innovative Clinical Research, Inc
Lauderhill, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Sarkis Clinical Trials
Ocala, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Millenia Psychiatry & Research, Inc
Orlando, Florida, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
IRIS Research
Smyrna, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Phoenix Medical Research
Prairie Village, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
J Gary Booker, MD APMC
Shreveport, Louisiana, United States
Pharmasite Research, Inc
Baltimore, Maryland, United States
CBH Health
Rockville, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States
BTC of New Bedford
New Bedford, Massachusetts, United States
Coastal Research Associates
Weymouth, Massachusetts, United States
Precise Research Centers
Flowood, Mississippi, United States
Millennium Psychiatric Associates
Olivette, Missouri, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Pharmaceutical Research Associates Inc
Marlton, New Jersey, United States
The Medical Research Network, LLC
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Richard H. Weisler, MD, PA
Raleigh, North Carolina, United States
Patient Priority Clinical Site, LLC
Cincinnati, Ohio, United States
The Ohio State University Department of Psychiatry
Columbus, Ohio, United States
Charak Clinical Research Center
Garfield Heights, Ohio, United States
Lindner Center of Hope
Mason, Ohio, United States
Professional Psychiatric Services
Mason, Ohio, United States
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, United States
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, United States
Community Clinical Research, Inc.
Austin, Texas, United States
BioBehavioral Research of Austin
Austin, Texas, United States
Relaro Medical Trials
Dallas, Texas, United States
El Campo Clinical Trials
El Campo, Texas, United States
Earle Research
Houston, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Family Psychiatry of The Wood
The Woodlands, Texas, United States
PRA Health Sciences
Salt Lake City, Utah, United States
Pacific Institute of Medical Sciences
Bothell, Washington, United States
Eastside Therapeutic Resource
Everett, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance.
Other Identifiers
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RAP-MD-02
Identifier Type: -
Identifier Source: org_study_id