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A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951988
Recruitment Status : Completed
First Posted : November 1, 2016
Results First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Study Description
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Brief Summary:
This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) 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-matching Rapastinel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Actual Study Start Date : November 13, 2016
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : February 22, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rapastinel 450 mg Weekly
Rapastinel 450 milligrams (mg) intravenous (IV) once a week during OLTP followed by rapastinel 450 mg IV once a week during DBTP.
 Drug: Rapastinel
Rapastinel pre-filled syringes for IV injections.
Experimental: Rapastinel 450 mg Every 2 Weeks
Rapastinel 450 mg IV once a week during OLTP followed by rapastinel 450 mg IV once every 2 weeks during DBTP.
 Drug: Rapastinel
Rapastinel pre-filled syringes for IV injections.
Placebo Comparator: Placebo
Rapastinel 450 mg IV once a week during OLTP followed by placebo-matching rapastinel 450 mg IV once a week during DBTP.
 Drug: Placebo-matching Rapastinel
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.


Outcome Measures
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Primary Outcome Measures :
  1. Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period [ Time Frame: 52 Weeks ]
    The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.

  2. Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales [ Time Frame: 104 Weeks ]

    On the C-SSRS, the 5 types of suicidal ideation are:

    Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"



Secondary Outcome Measures :
  1. Time to First Relapse During the Entire Double-Blind Treatment Period [ Time Frame: 104 Weeks ]
    The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Screening
  • 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 Screening
  • 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.
Contacts and Locations
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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): NCT02951988


Locations
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Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Jenna Hoogerheyde Allergan
  Study Documents (Full-Text)

Documents provided by Naurex, Inc, an affiliate of Allergan plc:
Study Protocol  [PDF] November 6, 2018
Statistical Analysis Plan  [PDF] December 13, 2018

More Information
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Additional Information:

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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02951988    
Other Study ID Numbers: RAP-MD-04
First Posted: November 1, 2016    Key Record Dates
Results First Posted: March 9, 2020
Last Update Posted: March 9, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms