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

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

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Rapastinel; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0107
      • The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
  • California
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network, LLC
    • Glendale, California, United States, 91206-4282
      • Behavioral Research Specialists, LLC
    • Panorama City, California, United States, 91402
      • Asclepes Research Centers
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Institute of Living
  • Florida
    • Hialeah, Florida, United States, 33012
      • Innovative Clinical Research, INC
    • Oakland Park, Florida, United States, 33334
      • Research Centers of America, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research (ACMR)
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Alexian Brothers Center for Psychiatric Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Ohio
    • Cincinnati, Ohio, United States, 45220-2288
      • Cincinnati VA Medical Center
  • Texas
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research, LLC
  • Virginia
    • Roanoke, Virginia, United States, 24014-2419
      • Carilion Medical Center, a Virginia Nonprofit Corporation
    • Salem, Virginia, United States, 24153
      • Department of Veterans Affairs Salem VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapastinel 450mg; Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.	Drug: Rapastinel; Rapastinel pre-filled syringes for weekly IV injections.
Placebo Comparator: Placebo; Placebo-matching rapastinel weekly IV injections.	Drug: Placebo; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 1 Day
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.	Baseline and 1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 28 Days
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.	Baseline and 28 Days

Collaborators and Investigators

• Sponsor: Naurex, Inc, an affiliate of Allergan plc

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): June 21, 2019
• Study Completion (Actual): June 21, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: RAP-MD-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No