Study of Rapastinel as Monotherapy in Patients With MDD

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03560518
• Other study ID #: RAP-MD-32
• Status: Terminated
• Phase: Phase 3
• Start date: June 15, 2018
• Est. completion date: July 8, 2019

Study information

• Verified date: August 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) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 439
• Est. completion date: July 8, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 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 8 weeks and not exceeding 18 months in duration at Visit 1

• Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode

• 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 6 months before Visit 1

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration)
• Placebo
Placebo (prefilled syringe, weekly IV administration)

Locations

Country	Name	City	State
United States	California Pharmaceutical Research Institute, Inc.	Anaheim	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Institute for Advanced Medical Research	Atlanta	Georgia
United States	Donald J. Garcia, Jr., MD, PA	Austin	Texas
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Hassman Research Institute	Berlin	New Jersey
United States	Boston Clinical Trials	Boston	Massachusetts
United States	New Hope Clinical Research Inc.	Charlotte	North Carolina
United States	Millennium Psychiatric Associates, LLC	Creve Coeur	Missouri
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Precise Research Centers	Flowood	Mississippi
United States	CBH Health, LLC	Gaithersburg	Maryland
United States	Collaborative Neuroscience Network	Garden Grove	California
United States	Research Centers of America, LLC	Hollywood	Florida
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Altea Research Institute	Las Vegas	Nevada
United States	Innovative Clinical Research, Inc.	Lauderhill	Florida
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Suburban Research Associates	Media	Pennsylvania
United States	Innova Clinical Trials	Miami	Florida
United States	Bioscience Research LLC	Mount Kisco	New York
United States	Synergy Research San Diego	National City	California
United States	Eastside Comprehensive Medical Center, LLC	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Keystone Clinical Studies, LLC	Norristown	Pennsylvania
United States	Excell Research Inc.	Oceanside	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	NRC Research Institute	Orange	California
United States	Alea Research	Phoenix	Arizona
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Artemis Institute for Clinical Research	San Diego	California
United States	California Neuroscience Research Medical Group,Inc.	Sherman Oaks	California
United States	Iris Research, Inc.	Smyrna	Georgia
United States	Viking Clinical Research Ltd.	Temecula	California
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Adams Clinical	Watertown	Massachusetts

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 on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6)	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 to end of Week 6
Secondary	Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment	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 to Day 1 post-first dose