Study of Rapastinel as Monotherapy in Patients With MDD



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:1/9/2019
Start Date:June 15, 2018
End Date:February 29, 2020
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@Allergan.com
Phone:877-277-8566

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A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900
milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive
disorder (MDD).


Inclusion Criteria:

- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
criteria for MDD

- Current major depressive episode of at least 8 weeks and not exceeding 18 months in
duration at Visit 1

- Treatment naive in the current episode or have inadequate response to 1-3
antidepressant therapies given at adequate dose and duration in the current episode

- 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
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Flowood, Mississippi 39232
Phone: 601-420-5810
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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3015 Flowers Road South
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Austin, Texas 78737
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Boston, Massachusetts 02135
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Charlotte, North Carolina 28204
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Creve Coeur, Missouri 63141
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Dayton, Ohio 45408
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Decatur, Georgia 30030
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Gaithersburg, Maryland 20877
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Garden Grove, California 92845
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Hoffman Estates, Illinois 60169
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7261 Sheridan Street
Hollywood, Florida 33024
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Jacksonville, Florida 32216
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Libertyville, Illinois 60048
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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
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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
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
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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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Rochester, New York 14618
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San Diego, California 92123
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Temecula, California 92591
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Upland, California 91786
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521 Mount Auburn Street
Watertown, Massachusetts 02472
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