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A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

Primary Purpose

Depressive Disorder, Major

Status
Terminated
Phase
Phase 2
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 4 weeks and not exceeding 24 months in duration at visit 1
  • Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
  • 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 1 month before Visit 1.

  • Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
  • Prior participation in any investigational study of rapastinel/GLYX-13

Sites / Locations

  • The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
  • Collaborative NeuroScience Network, LLC
  • Behavioral Research Specialists, LLC
  • Asclepes Research Centers
  • Institute of Living
  • Innovative Clinical Research, Inc
  • Research Centers of America, LLC
  • Atlanta Center for Medical Research (ACMR)
  • Alexian Brothers Center for Psychiatric Research
  • Lake Charles Clinical Trials
  • CBH Health
  • Altea Research Institute
  • Icahn School of Medicine at Mount Sinai
  • Cincinnati VA Medical Center
  • Pillar Clinical Research, LLC
  • Carilion Medical Center, a Virginia Nonprofit Corporation
  • Department of Veterans Affairs Salem VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rapastinel 450mg

Placebo

Arm Description

Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.

Placebo-matching rapastinel weekly IV injections.

Outcomes

Primary Outcome Measures

Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 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.
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.

Secondary Outcome Measures

Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 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.
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.

Full Information

First Posted
November 21, 2017
Last Updated
July 31, 2020
Sponsor
Naurex, Inc, an affiliate of Allergan plc
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1. Study Identification

Unique Protocol Identification Number
NCT03352453
Brief Title
A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to business reasons.
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 21, 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
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapastinel 450mg
Arm Type
Experimental
Arm Description
Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching rapastinel weekly IV injections.
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
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 and 1 Day
Title
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
Description
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.
Time Frame
Baseline and 1 Day
Secondary Outcome Measure Information:
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 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 and 28 Days
Title
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
Description
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.
Time Frame
Baseline and 28 Days

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 4 weeks and not exceeding 24 months in duration at visit 1 Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator 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 1 month before Visit 1. Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator. Prior participation in any investigational study of rapastinel/GLYX-13
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenna Hoogerheyde
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0107
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
91206-4282
Country
United States
Facility Name
Asclepes Research Centers
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Innovative Clinical Research, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Centers of America, LLC
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Atlanta Center for Medical Research (ACMR)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
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
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
CBH Health
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2288
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Carilion Medical Center, a Virginia Nonprofit Corporation
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014-2419
Country
United States
Facility Name
Department of Veterans Affairs Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.allerganclinicaltrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

Learn more about this trial

A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

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