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

July 1, 2020 updated by: Naurex, Inc, an affiliate of Allergan plc

An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
Time Frame: 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.
Up to 45 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naurex, Inc, an affiliate of Allergan plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

July 3, 2019

Study Completion (Actual)

July 3, 2019

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAP-MD-99

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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