A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03352453
• Other study ID #: RAP-MD-20
• Status: Terminated
• Phase: Phase 2
• Start date: December 15, 2017
• Est. completion date: June 21, 2019

Study information

• Verified date: July 2020
• Source: Naurex, Inc, an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 138
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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 4 weeks and not exceeding 24 months in duration at visit 1

• Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator

• If female of childbearing potential, have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test.

Exclusion Criteria:

• DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 1 month before Visit 1.

• Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.

• Prior participation in any investigational study of rapastinel/GLYX-13

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.
• Placebo
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research (ACMR)	Atlanta	Georgia
United States	The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	CBH Health	Gaithersburg	Maryland
United States	Collaborative NeuroScience Network, LLC	Garden Grove	California
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Institute of Living	Hartford	Connecticut
United States	Innovative Clinical Research, Inc	Hialeah	Florida
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Altea Research Institute	Las Vegas	Nevada
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Research Centers of America, LLC	Oakland Park	Florida
United States	Asclepes Research Centers	Panorama City	California
United States	Pillar Clinical Research, LLC	Richardson	Texas
United States	Carilion Medical Center, a Virginia Nonprofit Corporation	Roanoke	Virginia
United States	Department of Veterans Affairs Salem VA Medical Center	Salem	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Naurex, Inc, an affiliate of Allergan plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 a 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.	Baseline and 1 Day
Primary	Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score	The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.	Baseline and 1 Day
Secondary	Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 a 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.	Baseline and 28 Days
Secondary	Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score	The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.	Baseline and 28 Days

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.