Back to resultsStudy of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
Primary Purpose
Depressive Disorder, Major
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rapastinel
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression
Eligibility 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:
- 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
Sites / Locations
- University of Alabama at Birmingham
- Harmonex Neuroscience Research
- NoesisPharma
- Woodland International Research Group
- Woodland Research Northwest
- California Pharmaceutical Research Institute, Inc
- Southern California Research LLC.
- ATP Clinical Research Inc.
- ProScience Research Group
- Pharmacology Research Institute
- Behavioral Research Specialists, LLC
- Sun Valley Research Center
- Irvine Center for Clinical Research, Inc
- Synergy Clinical Research Center of Escondido
- Pharmacology Research Institute
- CITrials
- California Neuroscience Research
- Viking Clinical Research
- Pacific Clinical Research Medical
- Comprehensive Psychiatric Care
- Gulfcoast Clinical Research Center
- Reliable Clinical Research
- Meridien Research
- Innovative Clinical Research, Inc
- Research Centers of America
- Medical Research Group of Central Florida
- David A. Medina, MD
- Institute for Advanced Medical Research
- iResearch Atlanta, LLC
- Northwest Behavioral Research Center
- Attalla Consultants, LLC
- Alexian Brothers Center for Psychiatric Research
- Capstone Clinical Research
- AMR - Baber Research, Inc.
- University of Kansas School of Medicine Clinical Trial Unit
- Lake Charles Clinical Trials
- Louisiana Clinical Research
- ActivMed Practices & Research, Inc.
- Coastal Research Associates
- University of Massachusetts Medical School
- Precise Research Centers
- Psychiatric Care and Research Center
- St. Charles Psychiatric Associates
- Premier Psychiatric Research Institute, LLC
- Healthy Perspectives - Innovative Mental Health Services. PLLC
- Bio Behavioral Health
- Albuquerque Neuroscience, Inc
- SPRI Clinical Trials, LLC
- Manhattan Behavioral Medicine
- Finger Lakes Clinical Research
- Richmond Behavioral Associates
- Patient Priority Clinical Sites
- The Ohio State University Department of Psychiatry
- Midwest Clinical Research Center LLC
- Professional Psychiatric Services
- Red River Medical Research Center, LLC
- Sooner Clinical Research, Inc
- Paradigm Research Professionals
- Summit Research Network LLC
- Lehigh Center for Clinical Research
- Dr. Cherian Verghese
- Carolina Clinical Trials, Inc.
- Coastal Carolina Research Center
- Research Strategies of Memphis, LLC
- Donald J. Garcia, Jr., MD, PA
- Community Clinical Research
- Houston Clinical Trials
- North Texas Clinical Trials
- Earle Research
- Red Oak Psychiatry Associates, PA
- Clinical Trials of Texas
- Grayline Clinical Drug Trials
- Psychiatric and Behavioral Solutions
- Psychiatric Alliance of the Blue Ridge, Inc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rapastinel
Arm Description
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03668600
First Posted
August 28, 2018
Last Updated
July 1, 2020
Sponsor
Naurex, Inc, an affiliate of Allergan plc
1. Study Identification
Unique Protocol Identification Number
NCT03668600
Brief Title
Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
Official Title
An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Business decision to stop the program
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Naurex, Inc, an affiliate of Allergan plc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapastinel
Arm Type
Experimental
Arm Description
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Intervention Type
Drug
Intervention Name(s)
Rapastinel
Intervention Description
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Primary Outcome Measure Information:
Title
Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to 45 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenna Hoogerheyde
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Harmonex Neuroscience Research
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
NoesisPharma
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
California Pharmaceutical Research Institute, Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Southern California Research LLC.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
ATP Clinical Research Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
Irvine Center for Clinical Research, Inc
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Synergy Clinical Research Center of Escondido
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
CITrials
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
California Neuroscience Research
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Viking Clinical Research
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Pacific Clinical Research Medical
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Reliable Clinical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Innovative Clinical Research, Inc
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Research Centers of America
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
David A. Medina, MD
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Institute for Advanced Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Attalla Consultants, LLC
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30082
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
AMR - Baber Research, Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
University of Kansas School of Medicine Clinical Trial Unit
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Louisiana Clinical Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
ActivMed Practices & Research, Inc.
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Coastal Research Associates
City
South Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Psychiatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
St. Charles Psychiatric Associates
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Premier Psychiatric Research Institute, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Healthy Perspectives - Innovative Mental Health Services. PLLC
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Neuroscience, Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
SPRI Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Patient Priority Clinical Sites
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
The Ohio State University Department of Psychiatry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Midwest Clinical Research Center LLC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Professional Psychiatric Services
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Red River Medical Research Center, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Sooner Clinical Research, Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Paradigm Research Professionals
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Summit Research Network LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Dr. Cherian Verghese
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Carolina Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Strategies of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Donald J. Garcia, Jr., MD, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Houston Clinical Trials
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
North Texas Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Earle Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Red Oak Psychiatry Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Psychiatric and Behavioral Solutions
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
Facility Name
Psychiatric Alliance of the Blue Ridge, Inc
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Links:
URL
http://AllerganClinicalTrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.
Learn more about this trial
Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
We'll reach out to this number within 24 hrs