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A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)

Primary Purpose

Depressive Disorder, Major

Status
Completed
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

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 Visit 1
  • 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 Visit 1

  • Lifetime history of meeting DSM-5 criteria for:

    1. Schizophrenia spectrum or other psychotic disorder
    2. Bipolar or related disorder
    3. Major neurocognitive disorder
    4. 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
    5. Dissociative disorder
    6. Posttraumatic stress disorder
    7. MDD with psychotic features
  • Significant suicide risk, as judged by the Investigator.

Sites / Locations

  • Harmonex Neuroscience Research
  • NoesisPharma
  • Sun Valley Research Center
  • Irvine Center for Clinical Research, Inc
  • NRC Research Institute
  • Asclepes Research Centers
  • Artemis Institute for Clinical Research
  • MCB Clinical Research Center
  • Gulfcoast Clinical Research Center
  • Research Centers of America
  • Innova Clinical Trials Inc.
  • Combined Research Orlando Phase I-IV
  • Olympian Clinical Research
  • The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
  • Northwest Behavioral Research Center
  • AMR - Baber Research, Inc.
  • Psychiatric Associates
  • Louisiana Clinical Research
  • Sheppard Pratt Health System
  • University of Massachusetts Medical School
  • Psychiatric Care and Research Center
  • St. Charles Psychiatric Associates - Midwest Research Group
  • Alivation Research
  • Healthy Perspectives - Innovative Mental Health Services. PLLC
  • Hassman Research Institute, LLC
  • Global Medical Institute, LLC
  • Bio Behavioral Health
  • Albuquerque Neuroscience, Inc
  • SPRI Clinical Trials, Inc
  • Manhattan Behavioral Medicine
  • Fieve Clinical Research
  • New Hope Clinical Research Inc.
  • Dr. Cherian Verghese
  • Research Strategies of Memphis, LLC
  • Houston Clinical Trials, LLC
  • North Texas Clinical Trials
  • Grayline Clinical Drug Trials
  • Psychiatric and Behavioral Solutions
  • Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
  • Psychiatric Alliance of the Blue Ridge, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rapastinel 450 mg

Placebo

Arm Description

Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.

Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.

Outcomes

Primary Outcome Measures

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study
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 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
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 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.
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
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 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.
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
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 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
October 21, 2016
Last Updated
October 25, 2019
Sponsor
Naurex, Inc, an affiliate of Allergan plc
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1. Study Identification

Unique Protocol Identification Number
NCT02943577
Brief Title
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
November 21, 2018 (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) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapastinel 450 mg
Arm Type
Experimental
Arm Description
Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Intervention Type
Drug
Intervention Name(s)
Rapastinel
Intervention Description
Rapastinel pre-filled syringes for weekly IV injections.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Primary Outcome Measure Information:
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study
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 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 and 3 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in MADRS Total Score
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 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 and Day 8
Title
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
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 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 and Day 21
Title
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
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 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 and Day 8

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 Visit 1 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 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
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
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
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
Artemis Institute for Clinical Research
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
MCB Clinical Research Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Innova Clinical Trials Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
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
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
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
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
Louisiana Clinical Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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
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
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
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Fieve Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10168
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
Dr. Cherian Verghese
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
20006
Country
United States
Facility Name
Research Strategies of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Houston Clinical Trials, LLC
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
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
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

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 Major Depressive Disorder (RAP-MD-03)

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