Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)
NCT ID: NCT03614156
Last Updated: 2020-10-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
363 participants
INTERVENTIONAL
2018-08-02
2019-07-11
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 weekly
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
Rapastinel
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Rapastinel clinically driven schedule
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Rapastinel
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Placebo weekly
Placebo (prefilled syringe, weekly IV administration)
Placebo
Placebo (prefilled syringe, weekly IV administration)
Interventions
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Rapastinel
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Placebo
Placebo (prefilled syringe, weekly IV administration)
Eligibility Criteria
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Inclusion Criteria
* 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
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
Anaheim, 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
Hollywood, Florida, United States
Clinical NeuroscienceSolutions, 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
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
CBH Health
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
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
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
Bugát Pál Hospital, Clinexpert
Gyöngyös, , Hungary
Medical corporation Sato-Kai Yuge Hospital
Kumamoto, , Japan
Sagaarashiyama-Tanaka Clinic
Kyoto, , Japan
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku, , Japan
Yoyogi Mental Clinic
Shibuya-ku, , Japan
Maynds Tower Mental Clinic
Shibuya-ku, , Japan
Ohwa Mental Clinic
Toshima-ku, , Japan
Centrum Medyczne Luxmed Sp.z o.o.
Lublin, , Poland
VAVRUŠOVÁ CONSULTING s.r.o., Psychiatrická ambulancia
Bratislava, , Slovakia
MENTUM, s.r.o.
Bratislava Mestská Časť Ružinov, , Slovakia
Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
Liptovský Mikuláš, , Slovakia
PsychoLine s.r.o., Psychiatrická ambulancia
Rimavská Sobota, , Slovakia
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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2018-000064-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RAP-MD-33
Identifier Type: -
Identifier Source: org_study_id
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