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

Phase 3CompletedNCT03002077

Naurex, Inc, an affiliate of Allergan plc617 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

617

Conditions

Depressive Disorder, Major

Interventions

RapastinelDRUG

Rapastinel pre-filled syringes for IV injections.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (128)

Outcomes

Primary Outcomes

The Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame: 52 Weeks

Secondary Outcomes

Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+)

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.

Time frame: Baseline to 52 Weeks

Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS)

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.

Time frame: Baseline to 52 Weeks

Data from ClinicalTrials.gov

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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

...and 118 more locations