A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
NCT ID: NCT02943577
Last Updated: 2019-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
429 participants
INTERVENTIONAL
2016-11-02
2018-11-21
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 450 mg
Rapastinel 450 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.
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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Harmonex Neuroscience Research
Dothan, Alabama, United States
NoesisPharma
Phoenix, Arizona, United States
Sun Valley Research Center
Imperial, California, United States
Irvine Center for Clinical Research, Inc
Irvine, California, United States
NRC Research Institute
Orange, California, United States
Asclepes Research Centers
Panorama City, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
MCB Clinical Research Center
Colorado Springs, Colorado, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Innova Clinical Trials Inc.
Miami, Florida, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
Tampa, Florida, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
AMR - Baber Research, Inc.
Naperville, Illinois, United States
Psychiatric Associates
Overland Park, Kansas, United States
Louisiana Clinical Research
Shreveport, Louisiana, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Alivation Research
Lincoln, Nebraska, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, United States
Hassman Research Institute, LLC
Berlin, New Jersey, United States
Global Medical Institute, LLC
Princeton, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, United States
SPRI Clinical Trials, Inc
Brooklyn, New York, United States
Manhattan Behavioral Medicine
New York, New York, United States
Fieve Clinical Research
New York, New York, United States
New Hope Clinical Research Inc.
Charlotte, North Carolina, United States
Dr. Cherian Verghese
Norristown, Pennsylvania, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States
Houston Clinical Trials, LLC
Bellaire, Texas, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, United States
Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
Charlottesville, Virginia, United States
Psychiatric Alliance of the Blue Ridge, Inc.
Charlottesville, Virginia, 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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More Information
Other Identifiers
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RAP-MD-03
Identifier Type: -
Identifier Source: org_study_id
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