Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)
- Registration Number
- NCT03614156
- Lead Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Brief Summary
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 363
- Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
- 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:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo weekly Placebo Placebo (prefilled syringe, weekly IV administration) Rapastinel weekly Rapastinel Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) Rapastinel clinically driven schedule Rapastinel Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
- Primary Outcome Measures
Name Time Method Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP) 52 Weeks The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (52)
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Synergy Research San Diego
🇺🇸National City, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Excell Research Inc.
🇺🇸Oceanside, 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
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Clinical NeuroscienceSolutions, Inc.
🇺🇸Jacksonville, Florida, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Iris Research, Inc.
🇺🇸Smyrna, Georgia, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Millennium Psychiatric Associates, LLC
🇺🇸Creve Coeur, Missouri, 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
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Ohwa Mental Clinic
🇯🇵Toshima-ku, Japan
Bugát Pál Hospital, Clinexpert
🇭🇺Gyongyos, Hungary
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Sagaarashiyama-Tanaka Clinic
🇯🇵Kyoto-shi, Japan
Medical corporation Sato-Kai Yuge Hospital
🇯🇵Kumamoto-shi, Japan
Yoyogi Mental Clinic
🇯🇵Shibuya-ku, Japan
Sangenjaya Neurology- Psychosomatic Clinic
🇯🇵Setagaya-ku, Japan
Centrum Medyczne Luxmed Sp.z o.o.
🇵🇱Lublin, Poland
Maynds Tower Mental Clinic
🇯🇵Shibuya-ku, Japan
MENTUM, s.r.o.
🇸🇰Bratislava Mestská Časť Ružinov, Slovakia
VAVRUŠOVÁ CONSULTING s.r.o., Psychiatrická ambulancia
🇸🇰Bratislava, Slovakia
Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
🇸🇰Liptovský Mikuláš, Slovakia
PsychoLine s.r.o., Psychiatrická ambulancia
🇸🇰Rimavská Sobota, Slovakia
Alea Research
🇺🇸Phoenix, Arizona, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
California Pharmaceutical Research Institute
🇺🇸Anaheim, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Research Centers of America
🇺🇸Hollywood, 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
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Donald J. Garcia, Jr., MD, PA
🇺🇸Austin, Texas, United States