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Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)

Primary Purpose

Depressive Disorder, Major

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rapastinel
Vortioxetine
Placebo
Sponsored by
Naurex, Inc, an affiliate of Allergan plc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Rapastinel

    Vortioxetine

    Placebo

    Arm Description

    Rapastinel (450 mg prefilled syringe, weekly intravenous IV administration).

    Vortixetine (10 mg with available dose increase to vortioxetine 20 mg oral daily after 3 weeks of administration).

    Placebo (prefilled syringe, weekly IV administration or oral daily).

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at the End of the Double Blind Treatment Period (DBTP) (end of Week 6)
    The MADRS, a clinician-rated scale, will be used to assess depressive symptomatology. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item will be scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.

    Secondary Outcome Measures

    Change from Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment
    The MADRS, a clinician-rated scale, will be used to assess depressive symptomatology. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item will be scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.

    Full Information

    First Posted
    February 25, 2019
    Last Updated
    July 17, 2019
    Sponsor
    Naurex, Inc, an affiliate of Allergan plc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03855865
    Brief Title
    Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)
    Official Title
    A Randomized, Double-blind, Placebo- and Active- Controlled, Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision to stop the program.
    Study Start Date
    July 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Naurex, Inc, an affiliate of Allergan plc

    4. Oversight

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

    5. Study Description

    Brief Summary
    The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to 10 mg of Vortixetine and placebo in participants with major depressive disorder (MDD).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Disorder, Major

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rapastinel
    Arm Type
    Experimental
    Arm Description
    Rapastinel (450 mg prefilled syringe, weekly intravenous IV administration).
    Arm Title
    Vortioxetine
    Arm Type
    Active Comparator
    Arm Description
    Vortixetine (10 mg with available dose increase to vortioxetine 20 mg oral daily after 3 weeks of administration).
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (prefilled syringe, weekly IV administration or oral daily).
    Intervention Type
    Drug
    Intervention Name(s)
    Rapastinel
    Intervention Description
    Rapastinel (prefilled syringe, weekly intravenous IV administration).
    Intervention Type
    Drug
    Intervention Name(s)
    Vortioxetine
    Intervention Description
    Vortixetine (10 mg with available dose increase to vortioxetine 20 mg oral daily after 3 weeks of administration).
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo (prefilled syringe, weekly IV administration or oral daily).
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at the End of the Double Blind Treatment Period (DBTP) (end of Week 6)
    Description
    The MADRS, a clinician-rated scale, will be used to assess depressive symptomatology. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item will be scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
    Time Frame
    Baseline to end of Week 6
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment
    Description
    The MADRS, a clinician-rated scale, will be used to assess depressive symptomatology. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item will be scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
    Time Frame
    Baseline to Day 1 post-first dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 Visit 1 Have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode 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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marc Debelle
    Organizational Affiliation
    Allergan
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
    IPD Sharing Time Frame
    After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
    IPD Sharing Access Criteria
    To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
    IPD Sharing URL
    http://www.allerganclinicaltrials.com/
    Links:
    URL
    http://AllerganClinicalTrials.com
    Description
    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

    Learn more about this trial

    Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)

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