Status:
TERMINATED
A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
Lead Sponsor:
Naurex, Inc, an affiliate of Allergan plc
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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 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
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2019
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT03352453
Start Date
December 15 2017
End Date
June 21 2019
Last Update
August 14 2020
Active Locations (17)
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1
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0107
2
Collaborative NeuroScience Network, LLC
Garden Grove, California, United States, 92845
3
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206-4282
4
Asclepes Research Centers
Panorama City, California, United States, 91402