Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)

A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 363
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Gyongyos, Hungary, 3200
    • Bugát Pál Hospital, Clinexpert
• Japan
  • Kumamoto-shi, Japan, 861-8002
    • Medical corporation Sato-Kai Yuge Hospital
  • Kyoto-shi, Japan, 616-8421
    • Sagaarashiyama-Tanaka Clinic
  • Setagaya-ku, Japan, 154-0004
    • Sangenjaya Neurology- Psychosomatic Clinic
  • Shibuya-ku, Japan, 151-0051
    • Yoyogi Mental Clinic
  • Shibuya-ku, Japan, 151-0053
    • Maynds Tower Mental Clinic
  • Toshima-ku, Japan, 170-0002
    • Ohwa Mental Clinic
• Poland
  • Lublin, Poland, 20-109
    • Centrum Medyczne Luxmed Sp.z o.o.
• Slovakia
  • Bratislava, Slovakia, 851 01
    • VAVRUŠOVÁ CONSULTING s.r.o., Psychiatrická ambulancia
  • Bratislava Mestská Časť Ružinov, Slovakia, 820 07
    • MENTUM, s.r.o.
  • Liptovský Mikuláš, Slovakia, 031 23
    • Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
  • Rimavská Sobota, Slovakia, 979 01
    • PsychoLine s.r.o., Psychiatrická ambulancia
• 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
    • 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
    • Jacksonville, Florida, United States, 32256
      • Clinical NeuroscienceSolutions, 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
    • Hoffman Estates, Illinois, United States, 60169
      • Alexian Brothers Center for Psychiatric Research
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health
  • 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, 10128
      • Eastside Comprehensive Medical Center
    • New York, New York, United States, 10028
      • Icahn School of Medicine at Mount Sinai
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • New Hope Clinical Research
  • 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: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: -

• Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
• 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 Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapastinel weekly; Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)	Drug: Rapastinel; Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Experimental: Rapastinel clinically driven schedule; Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)	Drug: Rapastinel; Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Placebo Comparator: Placebo weekly; 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
Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)	The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.	52 Weeks

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): August 2, 2018
• Primary Completion (Actual): July 11, 2019
• Study Completion (Actual): July 11, 2019

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 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-33; 2018-000064-28 (EudraCT Number)

Drug and device information, study documents

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