Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:3/23/2019
Start Date:August 2, 2018
End Date:July 3, 2021
Contact:Clinical Trial Registry Team
Email:IR-CTRegistration@Allergan.com
Phone:877-277-8566

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A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225
mg of Rapastinel compared to placebo in the prevention of relapse in participants with major
depressive disorder (MDD).


Inclusion Criteria: -

- Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32

- 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 6 months before Visit 1

- Lifetime history of meeting 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 suicide risk, as judged by the Investigator
We found this trial at
42
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Sherman Oaks, California 91403
Phone: 818-990-2671
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Anaheim, California 92804
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3015 Flowers Road South
Atlanta, Georgia 30341
Phone: 770-817-9200
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Austin, Texas 78737
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Baltimore, Maryland 21208
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Bellevue, Washington 98007
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Berlin, New Jersey
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Boston, Massachusetts 02135
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Charlotte, North Carolina 28204
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Creve Coeur, Missouri 63141
Phone: 314-298-0001
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Dayton, Ohio 45408
Phone: 937-424-1050
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Decatur, Georgia 30030
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Flowood, Mississippi 39232
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Gaithersburg, Maryland 20877
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Garden Grove, California 92845
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Hoffman Estates, Illinois 60169
Phone: 847-230-3958
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7261 Sheridan Street
Hollywood, Florida 33024
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Jacksonville, Florida 32256
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Las Vegas, Nevada 89102
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Lauderhill, Florida 33319
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Libertyville, Illinois 60048
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Little Rock, Arkansas 72211
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Media, Pennsylvania 19063
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1801 Coral Way
Miami, Florida 33133
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Mount Kisco, New York 10549
Phone: 914-385-0200
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1908 Sweetwater Road
National City, California 91950
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New York, New York 10021
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New York, New York 10128
Phone: 212-595-5012
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Norristown, Pennsylvania 19403
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Oceanside, California 92056
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Orange, California 92868
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Phoenix, Arizona 85012
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Rochester, New York 14618
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San Diego, California 92123
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Smyrna, Georgia 30080
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Temecula, California 92591
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Upland, California 91786
Phone: 909-920-3000
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521 Mount Auburn Street
Watertown, Massachusetts 02472
Phone: 617-744-8542
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