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



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:12/9/2018
Start Date:December 5, 2017
End Date:January 1, 2020
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@Allergan.com
Phone:1-877-277-8566

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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

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.


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
We found this trial at
28
sites
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
991
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Houston, TX
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
461
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Iowa City, IA
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Atlanta, Georgia 30331
Phone: 404-881-5800
436
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Atlanta, GA
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491
mi
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Birmingham, AL
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 203-414-0007
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
353
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Chapel Hill, NC
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Cincinnati, Ohio 45220
Phone: 513-226-3571
97
mi
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Cincinnati, OH
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6150 Diamond Centre Court
Fort Myers, Florida 33912
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Fort Myers, FL
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Gaithersburg, Maryland 20877
Phone: 301-251-4702
315
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Gaithersburg, MD
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Garden Grove, California 92845
Phone: 844-562-1212
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Garden Grove, CA
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Glendale, California 91204
Phone: 888-255-5798
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Glendale, CA
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Hartford, Connecticut 06106
Phone: 860-919-1574
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Hartford, CT
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Hialeah, Florida 33012
Phone: 800-730-7692
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Hialeah, FL
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Hines, Illinois 60141
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Hines, IL
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Hinsdale, Illinois 60521
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Hinsdale, IL
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Hoffman Estates, Illinois 60169
Phone: 847-882-1600
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Hoffman Estates, IL
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Lake Charles, Louisiana 70601
Phone: 337-515-5212
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Lake Charles, LA
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Las Vegas, Nevada 89102
Phone: 877-261-5701
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Las Vegas, NV
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Long Beach, CA
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Phone: 212-241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Oakland Park, Florida 33334
Phone: 954-900-7649
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Oakland Park, FL
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14860 Roscoe Boulevard
Panorama City, California 91402
Phone: 844-283-3649
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Panorama City, CA
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415
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Philadelphia, PA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Richardson, Texas 75080
Phone: 214-396-4844
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Richardson, TX
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1906 Belleview Avenue Southeast
Roanoke, Virginia 24014
Phone: 540-981-8582
250
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Roanoke, VA
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Salem, Virginia 24153
Phone: 540-982-2463
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Salem, VA
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Salisbury, North Carolina 28144
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Salisbury, NC
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950 Campbell Ave
West Haven, Connecticut 06516
(203) 932-5711
Phone: 203-932-5711
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
535
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West Haven, CT
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