A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
NCT ID: NCT02932943
Last Updated: 2019-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
465 participants
INTERVENTIONAL
2016-10-15
2018-11-08
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
QUADRUPLE
Study Groups
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Rapastinel 450 mg
Rapastinel 450 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.
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 stess 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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Southern California Research LLC.
Beverly Hills, California, United States
ATP Clinical Research Inc.
Costa Mesa, California, United States
Pharmacology Research Institute
Encino, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Synergy San Diego
Lemon Grove, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Excell Research
Oceanside, California, United States
Anderson Clinical Research
Redlands, California, United States
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
Sherman Oaks, California, United States
Viking Clinical Research
Temecula, California, United States
Pacific Clinical Research Medical
Upland, California, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Meridien Research
Bradenton, Florida, United States
MD Clinical
Hallandale, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Meridien Research
Lakeland, Florida, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Adams Clinical Trials
Watertown, Massachusetts, United States
Altea Research
Las Vegas, Nevada, United States
Bioscience Research
Mount Kisco, New York, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Midwest Clinical Research Center LLC
Dayton, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
NorthWest Clinical Research Center
Bellevue, 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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More Information
Other Identifiers
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RAP-MD-01
Identifier Type: -
Identifier Source: org_study_id
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