A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder



Status:Active, not recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:10/20/2018
Start Date:November 13, 2016
End Date:September 27, 2019

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A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams
(mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive
treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse 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 Screening

- Have no more than partial response (< 50% improvement) to ongoing treatment with a
protocol-allowed antidepressant

- 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 Screening

- 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
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Upland, California 91786
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
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Imperial, California 92251
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8200 SW 117th Ave # 210
Miami, Florida 33183
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Albuquerque, New Mexico 87109
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Austin, Texas 78737
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22903
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Cincinnati, Ohio 45242
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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830 6th Street South
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200 West Magnolia Avenue
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1002 Gemini Avenue
Houston, Texas 77058
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8550 Cuthills Circle
Lincoln, Nebraska 68526
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Methuen, Massachusetts 01844
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