A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
NCT ID: NCT03352453
Last Updated: 2020-08-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
138 participants
INTERVENTIONAL
2017-12-15
2019-06-21
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 450mg
Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.
Placebo
Placebo-matching rapastinel weekly IV injections.
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 4 weeks and not exceeding 24 months in duration at visit 1
* Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.
Exclusion Criteria
* Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
* Prior participation in any investigational study of rapastinel/GLYX-13
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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The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, United States
Collaborative NeuroScience Network, LLC
Garden Grove, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Asclepes Research Centers
Panorama City, California, United States
Institute of Living
Hartford, Connecticut, United States
Innovative Clinical Research, Inc
Hialeah, Florida, United States
Research Centers of America, LLC
Oakland Park, Florida, United States
Atlanta Center for Medical Research (ACMR)
Atlanta, Georgia, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
CBH Health
Gaithersburg, Maryland, United States
Altea Research Institute
Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Carilion Medical Center, a Virginia Nonprofit Corporation
Roanoke, Virginia, United States
Department of Veterans Affairs Salem VA Medical Center
Salem, Virginia, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com, please contact [email protected] for assistance.
Other Identifiers
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RAP-MD-20
Identifier Type: -
Identifier Source: org_study_id
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