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A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rapastinel
Placebo-matching Rapastinel
Sponsored by
Naurex, Inc, an affiliate of Allergan plc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Alabama at Birmingham
  • Harmonex Neuroscience Research
  • NoesisPharma
  • University of Arizona Department of Psychiatry
  • 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
  • Collaborative Neuroscience Network, LLC
  • Behavioral Research Specialists, LLC
  • Sun Valley Research Center
  • Irvine Center for Clinical Research, Inc
  • Synergy Clinical Research Center of Escondido
  • Synergy San Diego
  • Pharmacology Research Institute
  • Pacific Research Partners; LLC.
  • Excell Research
  • NRC Research Institute
  • Asclepes Research Centers
  • Anderson Clinical Research
  • CITrials
  • Artemis Institute for Clinical Research
  • PCSD Feighner Research
  • Artemis Institute for Clinical Research
  • Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
  • Viking Clinical Research
  • Pacific Clinical Research Medical
  • MCB Clinical Research Center
  • Comprehensive Psychiatric Care
  • Meridien Research
  • Gulfcoast Clinical Research Center
  • Sarkis Clinical Trials
  • MD Clinical
  • Reliable Clinical Research
  • Advanced Research Institute of Miami
  • Clinical Neuroscience Solutions, Inc
  • Meridien Research
  • Innovative Clinical Research, Inc
  • Innova Clinical Trials Inc.
  • International Research Associates, LLC
  • Research Centers of America
  • Sarkis Clinical Trials
  • Medical Research Group of Central Florida
  • Clinical Neuroscience Solutions, Inc
  • Combined Research Orlando Phase I-IV
  • Millenia Psychiatry & Research, Inc
  • Olympian Clinical Research
  • The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
  • Institute for Advanced Medical Research
  • Atlanta Center for Medical Research
  • iResearch Atlanta, LLC
  • Northwest Behavioral Research Center
  • IRIS Research
  • Great Lakes Clinical Trials
  • Alexian Brothers Center for Psychiatric Research
  • Capstone Clinical Research
  • AMR - Baber Research, Inc.
  • Psychiatric Associates
  • Phoenix Medical Research
  • Heartland Research Associates
  • Lake Charles Clinical Trials
  • Louisiana Clinical Research
  • J Gary Booker, MD APMC
  • Sheppard Pratt Health System
  • Pharmasite Research, Inc
  • CBH Health
  • Boston Clinical Trials
  • ActivMed Practices & Research, Inc.
  • BTC of New Bedford
  • Adams Clinical Trials
  • Coastal Research Associates
  • University of Massachusetts Medical School
  • Precise Research Centers
  • Millennium Psychiatric Associates
  • Psychiatric Care and Research Center
  • St. Charles Psychiatric Associates - Midwest Research Group
  • Alivation Research
  • Altea Research
  • Healthy Perspectives - Innovative Mental Health Services. PLLC
  • Hassman Research Institute, LLC
  • Center for Emotional Fitness
  • Pharmaceutical Research Associates Inc
  • Global Medical Institute, LLC
  • Bio Behavioral Health
  • Albuquerque Neuroscience, Inc
  • SPRI Clinical Trials, Inc
  • Bioscience Research
  • Manhattan Behavioral Medicine
  • Eastside Comprehensive Medical Center, LLC
  • The Medical Research Network, LLC
  • Fieve Clinical Research
  • Finger Lakes Clinical Research
  • Richmond Behavioral Associates
  • New Hope Clinical Research Inc.
  • Richard H. Weisler, MD, PA
  • Neuro-Behavioral Clinical Research, Inc
  • Patient Priority Clinical Site, LLC
  • University of Cincinnati
  • The Ohio State University Department of Psychiatry
  • Midwest Clinical Research Center LLC
  • Charak Clinical Research Center
  • Lindner Center of Hope
  • Professional Psychiatric Services
  • IPS Research
  • Red River Medical Research Center, LLC
  • Sooner Clinical Research, Inc
  • Paradigm Research Professionals
  • Summit Research Network
  • Lehigh Center for Clinical Research
  • Suburban Research Associates
  • Dr. Cherian Verghese
  • Carolina Clinical Trials, Inc.
  • Coastal Carolina Research Center, Inc.
  • Clinical Neuroscience Solutions, Inc
  • Research Strategies of Memphis, LLC
  • Donald J. Garcia, Jr., MD, PA
  • Community Clinical Research, Inc.
  • BioBehavioral Research of Austin
  • Houston Clinical Trials, LLC
  • Relaro Medical Trials
  • El Campo Clinical Trials
  • North Texas Clinical Trials
  • Earle Research
  • Red Oak Psychiatry Associates, PA
  • Clinical Trials of Texas
  • Family Psychiatry of The Wood
  • Grayline Clinical Drug Trials
  • Psychiatric and Behavioral Solutions
  • PRA Health Sciences
  • Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
  • Psychiatric Alliance of the Blue Ridge, Inc
  • NorthWest Clinical Research Center
  • Pacific Institute of Medical Sciences
  • Eastside Therapeutic Resource

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Rapastinel 450 mg Weekly

Rapastinel 450 mg Every 2 Weeks

Placebo

Arm Description

Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.

Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.

Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.

Outcomes

Primary Outcome Measures

Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"

Secondary Outcome Measures

Time to First Relapse During the Entire Double-Blind Treatment Period
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.

Full Information

First Posted
October 31, 2016
Last Updated
February 21, 2020
Sponsor
Naurex, Inc, an affiliate of Allergan plc
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1. Study Identification

Unique Protocol Identification Number
NCT02951988
Brief Title
A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 13, 2016 (Actual)
Primary Completion Date
February 22, 2019 (Actual)
Study Completion Date
February 22, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapastinel 450 mg Weekly
Arm Type
Experimental
Arm Description
Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
Arm Title
Rapastinel 450 mg Every 2 Weeks
Arm Type
Experimental
Arm Description
Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
Intervention Type
Drug
Intervention Name(s)
Rapastinel
Intervention Description
Rapastinel pre-filled syringes for IV injections.
Intervention Type
Drug
Intervention Name(s)
Placebo-matching Rapastinel
Intervention Description
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Primary Outcome Measure Information:
Title
Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period
Description
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Time Frame
52 Weeks
Title
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
Description
On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"
Time Frame
104 Weeks
Secondary Outcome Measure Information:
Title
Time to First Relapse During the Entire Double-Blind Treatment Period
Description
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Time Frame
104 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
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
85032
Country
United States
Facility Name
University of Arizona Department of Psychiatry
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
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
Collaborative Neuroscience Network, LLC
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
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
Synergy San Diego
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
Pacific Research Partners; LLC.
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Asclepes Research Centers
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
CITrials
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
PCSD Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
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
MCB Clinical Research Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Reliable Clinical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Advanced Research Institute of Miami
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
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
Innova Clinical Trials Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Research Centers of America
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Sarkis Clinical Trials
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
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
Clinical Neuroscience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Combined Research Orlando Phase I-IV
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Millenia Psychiatry & Research, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32839
Country
United States
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Institute for Advanced Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
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
IRIS Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
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
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Phoenix Medical Research
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
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
J Gary Booker, MD APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Pharmasite Research, Inc
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
CBH Health
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
ActivMed Practices & Research, Inc.
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
BTC of New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Adams Clinical Trials
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Coastal Research Associates
City
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
Millennium Psychiatric Associates
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
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 - Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Alivation Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Altea Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
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
Hassman Research Institute, LLC
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Pharmaceutical Research Associates Inc
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Global Medical Institute, LLC
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
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, Inc
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Bioscience Research
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Eastside Comprehensive Medical Center, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Fieve Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10168
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
New Hope Clinical Research Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Richard H. Weisler, MD, PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Patient Priority Clinical Site, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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
Charak Clinical Research Center
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Lindner Center of Hope
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Professional Psychiatric Services
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
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
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
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Dr. Cherian Verghese
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
20006
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, Inc.
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
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, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
BioBehavioral Research of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Houston Clinical Trials, LLC
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Relaro Medical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
El Campo Clinical Trials
City
El Campo
State/Province
Texas
ZIP/Postal Code
77347
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
Family Psychiatry of The Wood
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
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
PRA Health Sciences
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Psychiatric Alliance of the Blue Ridge, Inc
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
NorthWest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Pacific Institute of Medical Sciences
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

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