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Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03668600
Recruitment Status : Terminated (Business decision to stop the program)
First Posted : September 12, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Rapastinel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder
Actual Study Start Date : August 23, 2018
Actual Primary Completion Date : July 3, 2019
Actual Study Completion Date : July 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Drug: 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 :
  1. Count of participants experiencing one or more Treatment emergent adverse events (TEAs) [ Time Frame: NDA submission date to 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Suicide risk, as determined by meeting any of the following criteria:

    1. A suicide attempt within the past year
    2. 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
    3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668600


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
United States, Arizona
NoesisPharma
Phoenix, Arizona, United States, 85016
United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
United States, California
California Pharmaceutical Research Institute, Inc
Anaheim, California, United States, 92804
Southern California Research LLC.
Beverly Hills, California, United States, 90036
ATP Clinical Research Inc.
Costa Mesa, California, United States, 92626
ProScience Research Group
Culver City, California, United States, 90230
Pharmacology Research Institute
Encino, California, United States, 91316
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
Sun Valley Research Center
Imperial, California, United States, 92251
Irvine Center for Clinical Research, Inc
Irvine, California, United States, 92614
Synergy Clinical Research Center of Escondido
Lemon Grove, California, United States, 91945
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
CITrials
Riverside, California, United States, 92506
California Neuroscience Research
Sherman Oaks, California, United States, 91403
Viking Clinical Research
Temecula, California, United States, 92591
Pacific Clinical Research Medical
Upland, California, United States, 91786
United States, Connecticut
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
Reliable Clinical Research
Hialeah, Florida, United States, 33012
Meridien Research
Lakeland, Florida, United States, 33805
Innovative Clinical Research, Inc
Lauderhill, Florida, United States, 33319
Research Centers of America
Oakland Park, Florida, United States, 33334
Medical Research Group of Central Florida
Orange City, Florida, United States, 32763
David A. Medina, MD
Orlando, Florida, United States, 32819
United States, Georgia
Institute for Advanced Medical Research
Atlanta, Georgia, United States, 30341
iResearch Atlanta, LLC
Decatur, Georgia, United States, 30030
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
Attalla Consultants, LLC
Smyrna, Georgia, United States, 30082
United States, Illinois
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States, 60169
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
AMR - Baber Research, Inc.
Naperville, Illinois, United States, 60563
United States, Kansas
University of Kansas School of Medicine Clinical Trial Unit
Wichita, Kansas, United States, 67214
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
Louisiana Clinical Research
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States, 01844
Coastal Research Associates
South Weymouth, Massachusetts, United States, 02190
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
Psychiatric Care and Research Center
O'Fallon, Missouri, United States, 63368
St. Charles Psychiatric Associates
Saint Charles, Missouri, United States, 63304
United States, Nebraska
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, New Mexico
Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, United States, 87109
United States, New York
SPRI Clinical Trials, LLC
Brooklyn, New York, United States, 11235
Manhattan Behavioral Medicine
New York, New York, United States, 10022
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
Patient Priority Clinical Sites
Cincinnati, Ohio, United States, 45215
The Ohio State University Department of Psychiatry
Columbus, Ohio, United States, 43210
Midwest Clinical Research Center LLC
Dayton, Ohio, United States, 45417
Professional Psychiatric Services
Mason, Ohio, United States, 45040
United States, Oklahoma
Red River Medical Research Center, LLC
Oklahoma City, Oklahoma, United States, 73112
Sooner Clinical Research, Inc
Oklahoma City, Oklahoma, United States, 73112
Paradigm Research Professionals
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
Summit Research Network LLC
Portland, Oregon, United States, 97210
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Dr. Cherian Verghese
Norristown, Pennsylvania, United States, 19403
United States, South Carolina
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States, 29407
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States, 38119
United States, Texas
Donald J. Garcia, Jr., MD, PA
Austin, Texas, United States, 78737
Community Clinical Research
Austin, Texas, United States, 78754
Houston Clinical Trials
Bellaire, Texas, United States, 77401
North Texas Clinical Trials
Fort Worth, Texas, United States, 76104
Earle Research
Houston, Texas, United States, 77058
Red Oak Psychiatry Associates, PA
Houston, Texas, United States, 77090
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
United States, Utah
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, United States, 84105
United States, Virginia
Psychiatric Alliance of the Blue Ridge, Inc
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Jenna Hoogerheyde Allergan

Additional Information:
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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT03668600     History of Changes
Other Study ID Numbers: RAP-MD-99
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naurex, Inc, an affiliate of Allergan plc:
Depression

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms