Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
- Registration Number
- NCT03002077
- Lead Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Brief Summary
This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 617
- 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 Screening
- 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.
- DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rapastinel Rapastinel Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.
- Primary Outcome Measures
Name Time Method The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) 52 Weeks An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+) Baseline to 52 Weeks The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement.
Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS) Baseline to 52 Weeks The Clinician Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences composed of 23 subjective self-reported and 5 objective observer-reported ratings, each scored from 0 (not at all) to 4 (extremely). Only the 23 subjective items will be collected and analyzed. The sum of each of the 23 subjective items was used for a total score of 0-92. A negative change from Baseline indicates improvement.
Trial Locations
- Locations (124)
Innova Clinical Trials Inc.
🇺🇸Miami, Florida, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
PCSD Feighner Research
🇺🇸San Diego, California, United States
Harmonex, Inc.
🇺🇸Dothan, Alabama, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
California Pharmaceutical Research Institute, Inc
🇺🇸Anaheim, California, United States
Southern California Research LLC.
🇺🇸Beverly Hills, California, United States
ATP Clinical Research Inc.
🇺🇸Costa Mesa, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸Garden Grove, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Irvine Center for Clinical Research, Inc
🇺🇸Irvine, California, United States
Synergy Clinical Research Center of Escondido
🇺🇸Lemon Grove, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Pacific Research Partners; LLC.
🇺🇸Oakland, California, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Asclepes Research Centers
🇺🇸Panorama City, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Excell Research
🇺🇸Oceanside, California, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
CITrials
🇺🇸Riverside, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Viking Clinical Research
🇺🇸Temecula, California, United States
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
🇺🇸Sherman Oaks, California, United States
Pacific Clinical Research Medical
🇺🇸Upland, California, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
MCB Clinical Research Center
🇺🇸Colorado Springs, Colorado, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Reliable Clinical Research
🇺🇸Hialeah, Florida, United States
Meridien Research
🇺🇸Lakeland, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Innovative Clinical Research, Inc
🇺🇸Lauderhill, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Institute for Advanced Medical Research
🇺🇸Atlanta, Georgia, United States
Research Centers of America
🇺🇸Oakland Park, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
Iris Research
🇺🇸Smyrna, Georgia, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Louisiana Clinical Research
🇺🇸Shreveport, Louisiana, United States
Sheppard Pratt Health System
🇺🇸Baltimore, Maryland, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
Pharmasite Research, Inc
🇺🇸Baltimore, Maryland, United States
ActivMed Practices & Research, Inc.
🇺🇸Methuen, Massachusetts, United States
Adams Clinical Trials
🇺🇸Watertown, Massachusetts, United States
Coastal Research Associates
🇺🇸South Weymouth, Massachusetts, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Psychiatric Care and Research Center
🇺🇸O'Fallon, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Millennium Psychiatric Associates
🇺🇸Saint Louis, Missouri, United States
Premier Psychiatric Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
SPRI Clinical Trials, Inc
🇺🇸Brooklyn, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Bioscience Research
🇺🇸Mount Kisco, New York, United States
Fieve Clinical Research
🇺🇸New York, New York, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
Eastside Comprehensive Medical Center, LLC
🇺🇸New York, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Carolina Clinical Trials, Inc.
🇺🇸Charleston, North Carolina, United States
New Hope Clinical Research Inc.
🇺🇸Charlotte, North Carolina, United States
Richard H. Weisler, MD, PA
🇺🇸Raleigh, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
Patient Priority Clinical Site, LLC
🇺🇸Cincinnati, Ohio, United States
The Ohio State University Department of Psychiatry
🇺🇸Columbus, Ohio, United States
Charak Clinical Research Center
🇺🇸Garfield Heights, Ohio, United States
Midwest Clinical Research Center LLC
🇺🇸Dayton, Ohio, United States
Lindner Center of Hope
🇺🇸Mason, Ohio, United States
Professional Psychiatric Services
🇺🇸Mason, Ohio, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Houston Clinical Trials, LLC
🇺🇸Bellaire, Texas, United States
Relaro Medical Trials
🇺🇸Dallas, Texas, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Earle Research
🇺🇸Houston, Texas, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Family Psychiatry of The Wood
🇺🇸The Woodlands, Texas, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Psychiatric Alliance of the Blue Ridge, Inc.
🇺🇸Charlottesville, Virginia, United States
NorthWest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Pacific Institute of Medical Sciences
🇺🇸Bothell, Washington, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Memphis, Tennessee, United States
Pharmaceutical Research Associates Inc
🇺🇸Marlton, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Woodland Research Northwest
🇺🇸Rogers, Arkansas, United States
Global Medical Institute, LLC
🇺🇸Princeton, New Jersey, United States
Coastal Carolina Research Center, Inc.
🇺🇸Mount Pleasant, South Carolina, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
🇺🇸Nashua, New Hampshire, United States
Altea Research
🇺🇸Las Vegas, Nevada, United States
J Gary Booker, MD APMC
🇺🇸Shreveport, Louisiana, United States
Hassman Research Institute, LLC
🇺🇸Berlin, New Jersey, United States
Research Strategies of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
NoesisPharma
🇺🇸Phoenix, Arizona, United States
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
Red River Medical Research Center, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Paradigm Research Professionals
🇺🇸Oklahoma City, Oklahoma, United States
Pharmaceutical Research Associates, Inc
🇺🇸Salt Lake City, Utah, United States
Sooner Clinical Research, Inc
🇺🇸Oklahoma City, Oklahoma, United States
Psychiatric and Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
University of South Florida, Psychiatry and Behavioral Neurosciences
🇺🇸Tampa, Florida, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
AMR - Baber Research, Inc.
🇺🇸Naperville, Illinois, United States
El Campo Clinical Trials
🇺🇸El Campo, Texas, United States
Combined Research Orlando Phase I-IV
🇺🇸Orlando, Florida, United States
Millenia Psychiatry & Research, Inc
🇺🇸Orlando, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Donald J. Garcia, Jr., MD, PA
🇺🇸Austin, Texas, United States
BioBehavioral Research of Austin
🇺🇸Austin, Texas, United States
Albuquerque Neuroscience, Inc
🇺🇸Albuquerque, New Mexico, United States