Study Stopped
Business decision to stop the program
Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder
1 other identifier
interventional
230
1 country
74
Brief Summary
Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2018
Shorter than P25 for phase_3
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 23, 2018
CompletedFirst Submitted
Initial submission to the registry
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2019
CompletedResults Posted
Study results publicly available
July 17, 2020
CompletedJuly 17, 2020
July 1, 2020
10 months
August 28, 2018
July 1, 2020
July 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
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.
Up to 45 Weeks
Study Arms (1)
Rapastinel
EXPERIMENTALRapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Interventions
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
NoesisPharma
Phoenix, Arizona, 85016, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Woodland Research Northwest
Rogers, Arkansas, 72758, United States
California Pharmaceutical Research Institute, Inc
Anaheim, California, 92804, United States
Southern California Research LLC.
Beverly Hills, California, 90036, United States
ATP Clinical Research Inc.
Costa Mesa, California, 92626, United States
ProScience Research Group
Culver City, California, 90230, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Irvine Center for Clinical Research, Inc
Irvine, California, 92614, United States
Synergy Clinical Research Center of Escondido
Lemon Grove, California, 91945, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
CITrials
Riverside, California, 92506, United States
California Neuroscience Research
Sherman Oaks, California, 91403, United States
Viking Clinical Research
Temecula, California, 92591, United States
Pacific Clinical Research Medical
Upland, California, 91786, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Reliable Clinical Research
Hialeah, Florida, 33012, United States
Meridien Research
Lakeland, Florida, 33805, United States
Innovative Clinical Research, Inc
Lauderhill, Florida, 33319, United States
Research Centers of America
Oakland Park, Florida, 33334, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
David A. Medina, MD
Orlando, Florida, 32819, United States
Institute for Advanced Medical Research
Atlanta, Georgia, 30341, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
Attalla Consultants, LLC
Smyrna, Georgia, 30082, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
AMR - Baber Research, Inc.
Naperville, Illinois, 60563, United States
University of Kansas School of Medicine Clinical Trial Unit
Wichita, Kansas, 67214, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629, United States
Louisiana Clinical Research
Shreveport, Louisiana, 71101, United States
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, 01844, United States
Coastal Research Associates
South Weymouth, Massachusetts, 02190, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63304, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, 03060, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, 87109, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Manhattan Behavioral Medicine
New York, New York, 10022, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, 45215, United States
The Ohio State University Department of Psychiatry
Columbus, Ohio, 43210, United States
Midwest Clinical Research Center LLC
Dayton, Ohio, 45417, United States
Professional Psychiatric Services
Mason, Ohio, 45040, United States
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, 73112, United States
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, 73112, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118, United States
Summit Research Network LLC
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Dr. Cherian Verghese
Norristown, Pennsylvania, 19403, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29407, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119, United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, 78737, United States
Community Clinical Research
Austin, Texas, 78754, United States
Houston Clinical Trials
Bellaire, Texas, 77401, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
Earle Research
Houston, Texas, 77058, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, 84105, United States
Psychiatric Alliance of the Blue Ridge, Inc
Charlottesville, Virginia, 22903, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Jenna Hoogerheyde
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2018
First Posted
September 12, 2018
Study Start
August 23, 2018
Primary Completion
July 3, 2019
Study Completion
July 3, 2019
Last Updated
July 17, 2020
Results First Posted
July 17, 2020
Record last verified: 2020-07