Study of Rapastinel as Monotherapy in Patients With MDD
NCT ID: NCT03560518
Last Updated: 2020-09-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
439 participants
INTERVENTIONAL
2018-06-15
2019-07-08
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
DOUBLE
Study Groups
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Rapastinel 450mg
Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration)
Rapastinel 900mg
Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration)
Placebo
Placebo (prefilled syringe, weekly IV administration)
Placebo
Placebo (prefilled syringe, weekly IV administration)
Interventions
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Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration)
Placebo
Placebo (prefilled syringe, weekly IV administration)
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
* Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
* 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:
* 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
18 Years
75 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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Alea Research
Phoenix, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
California Pharmaceutical Research Institute, Inc.
Anaheim, California, United States
Collaborative Neuroscience Network
Garden Grove, California, United States
Synergy Research San Diego
National City, California, United States
Excell Research Inc.
Oceanside, California, United States
NRC Research Institute
Orange, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
California Neuroscience Research Medical Group,Inc.
Sherman Oaks, California, United States
Viking Clinical Research Ltd.
Temecula, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Innova Clinical Trials
Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Institute for Advanced Medical Research
Atlanta, Georgia, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
Iris Research, Inc.
Smyrna, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
CBH Health, LLC
Gaithersburg, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Precise Research Centers
Flowood, Mississippi, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
Altea Research Institute
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Bioscience Research LLC
Mount Kisco, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
New Hope Clinical Research Inc.
Charlotte, North Carolina, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Suburban Research Associates
Media, Pennsylvania, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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RAP-MD-32
Identifier Type: -
Identifier Source: org_study_id
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