Study of Rapastinel as Monotherapy in Patients With MDD

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Alea Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
  • California
    • Anaheim, California, United States, 92804
      • California Pharmaceutical Research Institute, Inc.
    • Garden Grove, California, United States, 92845
      • Collaborative NeuroScience Network
    • National City, California, United States, 91950
      • Synergy Research San Diego
    • Oceanside, California, United States, 92056
      • Excell Research Inc.
    • Orange, California, United States, 92868
      • NRC Research Institute
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group,Inc.
    • Temecula, California, United States, 92591
      • Viking Clinical Research Ltd.
    • Upland, California, United States, 91786
      • Pacific Clinical Research Medical Group
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Centers of America, LLC
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Lauderhill, Florida, United States, 33319
      • Innovative Clinical Research, Inc.
    • Miami, Florida, United States, 33133
      • Innova Clinical Trials
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Atlanta, Georgia, United States, 30341
      • Institute for Advanced Medical Research
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
    • Smyrna, Georgia, United States, 30082
      • Iris Research, Inc.
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Millennium Psychiatric Associates, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research LLC
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • New York, New York, United States, 10028
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10128
      • Eastside Comprehensive Medical Center, LLC
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • New Hope Clinical Research Inc.
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Norristown, Pennsylvania, United States, 19403
      • Keystone Clinical Studies, LLC
  • Texas
    • Austin, Texas, United States, 78737
      • Donald J. Garcia, Jr., MD, PA
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapastinel 450mg; Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)	Drug: Rapastinel; Rapastinel (prefilled syringe, weekly intravenous IV administration)
Experimental: Rapastinel 900mg; Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)	Drug: Rapastinel; Rapastinel (prefilled syringe, weekly intravenous IV administration)
Placebo Comparator: Placebo; Placebo (prefilled syringe, weekly IV administration)	Drug: Placebo; Placebo (prefilled syringe, weekly IV administration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to end of Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Day 1 post-first dose

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): July 8, 2019
• Study Completion (Actual): July 8, 2019

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 15, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: RAP-MD-32

Drug and device information, study documents

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