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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Terminated
Sponsor
Naurex, Inc, an affiliate of Allergan plc

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.