Research Study Summary
An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
To Learn more
CW ID: 223461
Date Last Changed:
March 13, 2017
Clinical Trial Snapshot
- Both Male and Female
- 18 to 65 Years
- Overall Status
- Facility Type
- 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 ß-human chorionic gonadotropin (ß-hCG) pregnancy test.
- 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:
- Schizophrenia spectrum or other psychotic disorder
- Bipolar or related disorder
- Major neurocognitive disorder
- 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
- Dissociative disorder
- Posttraumatic stress disorder
- MDD with psychotic features
- Significant suicide risk, as judged by the Investigator.
DISCLAIMER: CenterWatch does not conduct clinical research.
CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies,
contract research organizations, clinical research sites and other interested parties. This information
is designed to help patients find clinical trials of interest and contact the research centers
conducting the trials.