Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
Status: | Completed |
---|---|
Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 3/1/2019 |
Start Date: | February 3, 2017 |
End Date: | December 6, 2018 |
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 antidepressant therapy (ADT) in patients 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
134
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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30 Temple Street
Nashua, New Hampshire 03060
Nashua, New Hampshire 03060
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