A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder

This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 658
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Department of Psychiatry
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • California
    • Anaheim, California, United States, 92804
      • California Pharmaceutical Research Institute, Inc
    • Culver City, California, United States, 90230
      • ProScience Research Group
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Lemon Grove, California, United States, 91945
      • Synergy Clinical Research Center Of Escondido
    • Oakland, California, United States, 94607
      • Pacific Research Partners; LLC.
    • Riverside, California, United States, 92506
      • CITrials
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92108
      • PCSD Feighner Research
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33012
      • Reliable Clinical Research
    • Homestead, Florida, United States, 33030
      • Advanced Research Institute of Miami
    • Lauderhill, Florida, United States, 33319
      • Innovative Clinical Research, Inc
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC
    • Ocala, Florida, United States, 34474
      • Sarkis Clinical Trials
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc
    • Orlando, Florida, United States, 32839
      • Millenia Psychiatry & Research, Inc
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
    • Smyrna, Georgia, United States, 30080
      • IRIS Research
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
    • Hoffman Estates, Illinois, United States, 60169
      • Alexian Brothers Center for Psychiatric Research
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Phoenix Medical Research
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials
    • Shreveport, Louisiana, United States, 71104
      • J Gary Booker, MD APMC
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc
    • Rockville, Maryland, United States, 20850
      • CBH Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, Inc.
    • New Bedford, Massachusetts, United States, 02740
      • BTC of New Bedford
    • Weymouth, Massachusetts, United States, 02190
      • Coastal Research Associates
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Olivette, Missouri, United States, 63132
      • Millennium Psychiatric Associates
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Marlton, New Jersey, United States, 08053
      • Pharmaceutical Research Associates Inc
  • New York
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Richard H. Weisler, MD, PA
  • Ohio
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Site, LLC
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Department of Psychiatry
    • Garfield Heights, Ohio, United States, 44125
      • Charak Clinical Research Center
    • Mason, Ohio, United States, 45040
      • Professional Psychiatric Services
    • Mason, Ohio, United States, 45040
      • Lindner Center of HOPE
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Paradigm Research Professionals
    • Oklahoma City, Oklahoma, United States, 73112
      • Red River Medical Research Center, LLC
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research, Inc
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Carolina Clinical Trials, Inc.
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center, Inc.
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • Austin, Texas, United States, 78759
      • BioBehavioral Research of Austin
    • Dallas, Texas, United States, 75243
      • Relaro Medical Trials
    • El Campo, Texas, United States, 77347
      • El Campo Clinical Trials
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates, PA
    • Houston, Texas, United States, 77058
      • Earle Research
    • The Woodlands, Texas, United States, 77381
      • Family Psychiatry of The Wood
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • PRA Health Sciences
  • Washington
    • Bothell, Washington, United States, 98011
      • Pacific Institute of Medical Sciences
    • Everett, Washington, United States, 98201
      • Eastside Therapeutic Resource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapastinel 225 mg; Rapastinel 225 milligram (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.	Drug: Rapastinel; Rapastinel pre-filled syringes for weekly IV injections.
Experimental: Rapastinel 450 mg; Rapastinel 450 mg 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.	Drug: Rapastinel; Rapastinel pre-filled syringes for weekly IV injections.
Placebo Comparator: Placebo; 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.	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 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.	Baseline and 3 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Day 8

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. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): December 18, 2018

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

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-02

Drug and device information, study documents

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