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Study of Rapastinel as Monotherapy in Patients With MDD

Primary Purpose

Depressive Disorder, Major

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rapastinel
Placebo
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 focused on measuring Depression

Eligibility Criteria

18 Years - 75 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 Visit 1
  • Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
  • 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 Visit 1
  • 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

  • Alea Research
  • Woodland International Research Group
  • California Pharmaceutical Research Institute, Inc.
  • Collaborative Neuroscience Network
  • Synergy Research San Diego
  • Excell Research Inc.
  • NRC Research Institute
  • Artemis Institute for Clinical Research
  • California Neuroscience Research Medical Group,Inc.
  • Viking Clinical Research Ltd.
  • Pacific Clinical Research Medical Group
  • Research Centers of America, LLC
  • Clinical Neuroscience Solutions, Inc.
  • Innovative Clinical Research, Inc.
  • Innova Clinical Trials
  • Atlanta Center for Medical Research
  • Institute for Advanced Medical Research
  • iResearch Atlanta, LLC
  • Iris Research, Inc.
  • Capstone Clinical Research
  • Pharmasite Research, Inc.
  • CBH Health, LLC
  • Boston Clinical Trials
  • Adams Clinical
  • Precise Research Centers
  • Millennium Psychiatric Associates, LLC
  • Altea Research Institute
  • Hassman Research Institute
  • Bioscience Research LLC
  • Icahn School of Medicine at Mount Sinai
  • Eastside Comprehensive Medical Center, LLC
  • The Medical Research Network, LLC
  • Finger Lakes Clinical Research
  • New Hope Clinical Research Inc.
  • Midwest Clinical Research Center
  • IPS Research Company
  • Suburban Research Associates
  • Keystone Clinical Studies, LLC
  • Donald J. Garcia, Jr., MD, PA
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Rapastinel 450mg

Rapastinel 900mg

Placebo

Arm Description

Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)

Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)

Placebo (prefilled syringe, weekly IV administration)

Outcomes

Primary Outcome Measures

Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6)
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Secondary Outcome Measures

Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Full Information

First Posted
June 7, 2018
Last Updated
August 15, 2020
Sponsor
Naurex, Inc, an affiliate of Allergan plc
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1. Study Identification

Unique Protocol Identification Number
NCT03560518
Brief Title
Study of Rapastinel as Monotherapy in Patients With MDD
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Business decision to stop the program.
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
July 8, 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
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo 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
Keywords
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapastinel 450mg
Arm Type
Experimental
Arm Description
Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
Arm Title
Rapastinel 900mg
Arm Type
Experimental
Arm Description
Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (prefilled syringe, weekly IV administration)
Intervention Type
Drug
Intervention Name(s)
Rapastinel
Intervention Description
Rapastinel (prefilled syringe, weekly intravenous IV administration)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (prefilled syringe, weekly IV administration)
Primary Outcome Measure Information:
Title
Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6)
Description
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time Frame
Baseline to end of Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment
Description
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time Frame
Baseline to Day 1 post-first dose

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: 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 Visit 1 Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode 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 Visit 1 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
Alea Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
California Pharmaceutical Research Institute, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Synergy Research San Diego
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Excell Research Inc.
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
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
California Neuroscience Research Medical Group,Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Viking Clinical Research Ltd.
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Research Centers of America, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
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
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
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
Iris Research, Inc.
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30082
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Pharmasite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
CBH Health, LLC
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
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, LLC
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Bioscience Research LLC
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10028
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
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
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
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Keystone Clinical Studies, LLC
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
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
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Rapastinel as Monotherapy in Patients With MDD

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