Study of Rapastinel as Monotherapy in Patients With MDD
- Registration Number
- NCT03560518
- Lead Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Brief Summary
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 439
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
- 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
- DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (prefilled syringe, weekly IV administration) Rapastinel 450mg Rapastinel Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration) Rapastinel 900mg Rapastinel Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
- Primary Outcome Measures
Name Time Method Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6) Baseline to end of Week 6 The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
- Secondary Outcome Measures
Name Time Method Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment Baseline to Day 1 post-first dose The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Trial Locations
- Locations (40)
California Pharmaceutical Research Institute, Inc.
🇺🇸Anaheim, California, United States
Research Centers of America, LLC
🇺🇸Hollywood, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, 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
California Neuroscience Research Medical Group,Inc.
🇺🇸Sherman Oaks, California, United States
Viking Clinical Research Ltd.
🇺🇸Temecula, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, 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
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Bioscience Research LLC
🇺🇸Mount Kisco, New York, United States
Millennium Psychiatric Associates, LLC
🇺🇸Creve Coeur, Missouri, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Eastside Comprehensive Medical Center, 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
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Alea Research
🇺🇸Phoenix, Arizona, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Innova Clinical Trials
🇺🇸Miami, Florida, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Donald J. Garcia, Jr., MD, PA
🇺🇸Austin, Texas, United States