NCT02943577 - A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03) | Crick

Overview

This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

429

Conditions

Depressive Disorder, Major

Interventions

RapastinelDRUG

Rapastinel pre-filled syringes for weekly IV injections.

PlaceboDRUG

Placebo-matching rapastinel pre-filled syringes for weekly 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 Visit 1 * 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 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.

Locations (40)

Outcomes

Primary Outcomes

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study

The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Time frame: Baseline and 3 Weeks

Secondary Outcomes

Change From Baseline in MADRS Total Score

The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Time frame: Baseline and Day 8

Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population

The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Time frame: Baseline and Day 21

Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population

The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.