A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)

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 rapastinel 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): 465
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90036
      • Southern California Research LLC.
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research Inc.
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network, LLC
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Oceanside, California, United States, 92056
      • Excell Research
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • Sherman Oaks, California, United States, 91403
      • Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
    • Temecula, California, United States, 92591
      • Viking Clinical Research
    • Upland, California, United States, 91786
      • Pacific Clinical Research Medical
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Comprehensive Psychiatric Care
  • Florida
    • Bradenton, Florida, United States, 34201
      • Meridien Research
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc
    • Lakeland, Florida, United States, 33805
      • Meridien Research
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Institute for Advanced Medical Research
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical Trials
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research
    • New York, New York, United States, 10128
      • Eastside Comprehensive Medical Center, LLC
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • Ohio
    • Canton, Ohio, United States, 44718
      • Neuro-Behavioral Clinical Research, Inc
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc
  • Texas
    • Austin, Texas, United States, 78737
      • Donald J. Garcia, Jr., MD, PA
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

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 stess 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rapastinel 450 mg; Rapastinel 450 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.
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 Trial	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
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.	Baseline and Day 21
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.	Baseline and Day 8

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2016
• Primary Completion (ACTUAL): September 21, 2018
• Study Completion (ACTUAL): November 8, 2018

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (ESTIMATE): October 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2019
• Last Update Submitted That Met QC Criteria: September 21, 2019
• Last Verified: September 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-01

Drug and device information, study documents

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