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A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03352453
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : December 7, 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) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Rapastinel Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapastinel 450mg
Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
Drug: Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.

Placebo Comparator: Placebo
Placebo-matching rapastinel weekly IV injections.
Drug: Placebo
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.




Primary Outcome Measures :
  1. Change from baseline in Montgomery-Asberg Depression Rating Scale) MADRS Total Score [ Time Frame: Baseline and 1 Day ]
    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 a 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.


Secondary Outcome Measures :
  1. Change from Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score [ Time Frame: Baseline and 1 Day ]
    The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. The scale is compatible with the FDA categories for prospective assessment of suicidal ideation and behavior. Developed for use as both a safety and efficacy outcome measure in research and in clinical settings, the scale is sensitive enough to detect an efficacy signal in conventional sample sizes used in clinical trials.



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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 4 weeks and not exceeding 24 months in duration at visit 1
  • Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
  • 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 1 month before Visit 1.
  • Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
  • Prior participation in any investigational study of rapastinel/GLYX-13

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): NCT03352453


Contacts
Contact: Clinical Trials Registry Team 1-877-277-8566 IR-CTRegistration@Allergan.com

  Show 28 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: NCT03352453     History of Changes
Other Study ID Numbers: RAP-MD-20
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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