Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
- Registration Number
- NCT03668600
- Lead Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Brief Summary
Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 230
- Completion of lead-in study
- Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator
-
Suicide risk, as determined by meeting any of the following criteria:
- A suicide attempt within the past year
- Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
- Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.
-
At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
-
Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation
-
Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rapastinel Rapastinel Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
- Primary Outcome Measures
Name Time Method Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) Up to 45 Weeks A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (73)
CITrials
🇺🇸Riverside, California, United States
Institute for Advanced Medical Research
🇺🇸Atlanta, Georgia, United States
The Ohio State University Department of Psychiatry
🇺🇸Columbus, Ohio, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Patient Priority Clinical Sites
🇺🇸Cincinnati, Ohio, United States
Earle Research
🇺🇸Houston, Texas, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Summit Research Network LLC
🇺🇸Portland, Oregon, United States
NoesisPharma
🇺🇸Phoenix, Arizona, United States
Sooner Clinical Research, Inc
🇺🇸Oklahoma City, Oklahoma, United States
Paradigm Research Professionals
🇺🇸Oklahoma City, Oklahoma, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Louisiana Clinical Research
🇺🇸Shreveport, Louisiana, United States
California Pharmaceutical Research Institute, Inc
🇺🇸Anaheim, California, United States
Reliable Clinical Research
🇺🇸Hialeah, Florida, United States
Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Innovative Clinical Research, Inc
🇺🇸Lauderhill, Florida, United States
Attalla Consultants, LLC
🇺🇸Smyrna, Georgia, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
Meridien Research
🇺🇸Lakeland, Florida, United States
ActivMed Practices & Research, Inc.
🇺🇸Methuen, Massachusetts, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Psychiatric Care and Research Center
🇺🇸O'Fallon, Missouri, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
🇺🇸Nashua, New Hampshire, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Synergy Clinical Research Center of Escondido
🇺🇸Lemon Grove, California, United States
Irvine Center for Clinical Research, Inc
🇺🇸Irvine, California, United States
California Neuroscience Research
🇺🇸Sherman Oaks, California, United States
Woodland Research Northwest
🇺🇸Rogers, Arkansas, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Pacific Clinical Research Medical
🇺🇸Upland, California, United States
Viking Clinical Research
🇺🇸Temecula, California, United States
AMR - Baber Research, Inc.
🇺🇸Naperville, Illinois, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
University of Kansas School of Medicine Clinical Trial Unit
🇺🇸Wichita, Kansas, United States
Coastal Research Associates
🇺🇸South Weymouth, Massachusetts, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
St. Charles Psychiatric Associates
🇺🇸Saint Charles, Missouri, United States
Premier Psychiatric Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
Midwest Clinical Research Center LLC
🇺🇸Dayton, Ohio, United States
Professional Psychiatric Services
🇺🇸Mason, Ohio, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Research Strategies of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
Houston Clinical Trials
🇺🇸Bellaire, Texas, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
ATP Clinical Research Inc.
🇺🇸Costa Mesa, California, United States
Research Centers of America
🇺🇸Oakland Park, Florida, United States
Southern California Research LLC.
🇺🇸Beverly Hills, California, United States
Psychiatric and Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
Psychiatric Alliance of the Blue Ridge, Inc
🇺🇸Charlottesville, Virginia, United States
Red River Medical Research Center, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Donald J. Garcia, Jr., MD, PA
🇺🇸Austin, Texas, United States
David A. Medina, MD
🇺🇸Orlando, Florida, United States
Carolina Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
Community Clinical Research
🇺🇸Austin, Texas, United States
Albuquerque Neuroscience, Inc
🇺🇸Albuquerque, New Mexico, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Dr. Cherian Verghese
🇺🇸Norristown, Pennsylvania, United States