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

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ClinicalTrials.gov Identifier: NCT03614156
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Rapastinel Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : July 3, 2021
Estimated Study Completion Date : July 3, 2021

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP) [ Time Frame: 52 Weeks ]
    Time in days from randomization to relapse. The primary efficacy analysis will compare the time to relapse between placebo and rapastinel treatment groups using the log-rank test.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614156


Contacts
Contact: Clinical Trial Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

  Show 55 Study Locations
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
Study Director: Robert Hayes, PhD Allergan

Additional Information:
Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT03614156     History of Changes
Other Study ID Numbers: RAP-MD-33
2018-000064-28 ( EudraCT Number )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naurex, Inc, an affiliate of Allergan plc:
Depression

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms