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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT03352453

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

138

Starts

2017-12-15

Expected to finish

2019-06-21

Last updated by the study team

2020-08-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham — Birmingham, Alabama, United States
• Collaborative NeuroScience Network, LLC — Garden Grove, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Asclepes Research Centers — Panorama City, California, United States
• Institute of Living — Hartford, Connecticut, United States
• Innovative Clinical Research, Inc — Hialeah, Florida, United States
• Research Centers of America, LLC — Oakland Park, Florida, United States
• Atlanta Center for Medical Research (ACMR) — Atlanta, Georgia, United States
• Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
• Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
• CBH Health — Gaithersburg, Maryland, United States
• Altea Research Institute — Las Vegas, Nevada, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cincinnati VA Medical Center — Cincinnati, Ohio, United States
• Pillar Clinical Research, LLC — Richardson, Texas, United States
• Carilion Medical Center, a Virginia Nonprofit Corporation — Roanoke, Virginia, United States
• Department of Veterans Affairs Salem VA Medical Center — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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