Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

Phase 3

Completed

Brief Summary: 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).

Recruitment & Eligibility

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:
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.

Arm && Interventions

Group	Intervention	Description
Rapastinel	Rapastinel	Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks.

Primary Outcome Measures

Name	Time	Method
The Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	52 Weeks	An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+)	Baseline to 52 Weeks	The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement.
Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS)	Baseline to 52 Weeks	The Clinician Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences composed of 23 subjective self-reported and 5 objective observer-reported ratings, each scored from 0 (not at all) to 4 (extremely). Only the 23 subjective items will be collected and analyzed. The sum of each of the 23 subjective items was used for a total score of 0-92. A negative change from Baseline indicates improvement.

Locations (124): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Harmonex, Inc.
🇺🇸
Dothan, Alabama, United States
NoesisPharma
🇺🇸
Phoenix, Arizona, United States
Woodland International Research Group
🇺🇸
Little Rock, Arkansas, United States
Woodland Research Northwest
🇺🇸
Rogers, Arkansas, United States
California Pharmaceutical Research Institute, Inc
🇺🇸
Anaheim, California, United States
Southern California Research LLC.
🇺🇸
Beverly Hills, California, United States
ATP Clinical Research Inc.
🇺🇸
Costa Mesa, California, United States
ProScience Research Group
🇺🇸
Culver City, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸
Garden Grove, California, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States