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 |
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).
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
sites
811 Juniper St NE
Atlanta, Georgia 30308
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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3015 Flowers Road South
Atlanta, Georgia 30341
Atlanta, Georgia 30341
Phone: 770-817-9200
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Hoffman Estates, Illinois 60169
Phone: 847-230-3958
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Sherman Oaks, California 91403
Phone: 818-990-2671
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