A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943564
• Other study ID #: RAP-MD-02
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2016
• Est. completion date: December 18, 2018

Study information

• Verified date: December 2019
• Source: Naurex, Inc, an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: December 18, 2018
• Est. primary completion date: December 12, 2018
• 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 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 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:

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.

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	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	California Pharmaceutical Research Institute, Inc	Anaheim	California
United States	BioBehavioral Research of Austin	Austin	Texas
United States	Community Clinical Research, Inc.	Austin	Texas
United States	Pharmasite Research, Inc	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Pacific Institute of Medical Sciences	Bothell	Washington
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Patient Priority Clinical Site, LLC	Cincinnati	Ohio
United States	The Ohio State University Department of Psychiatry	Columbus	Ohio
United States	ProScience Research Group	Culver City	California
United States	Relaro Medical Trials	Dallas	Texas
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	El Campo Clinical Trials	El Campo	Texas
United States	Eastside Therapeutic Resource	Everett	Washington
United States	Precise Research Centers	Flowood	Mississippi
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Charak Clinical Research Center	Garfield Heights	Ohio
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Reliable Clinical Research	Hialeah	Florida
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Advanced Research Institute of Miami	Homestead	Florida
United States	Earle Research	Houston	Texas
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Innovative Clinical Research, Inc	Lauderhill	Florida
United States	Synergy Clinical Research Center of Escondido	Lemon Grove	California
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Pharmaceutical Research Associates Inc	Marlton	New Jersey
United States	Lindner Center of Hope	Mason	Ohio
United States	Professional Psychiatric Services	Mason	Ohio
United States	Suburban Research Associates	Media	Pennsylvania
United States	ActivMed Practices & Research, Inc.	Methuen	Massachusetts
United States	International Research Associates, LLC	Miami	Florida
United States	Coastal Carolina Research Center, Inc.	Mount Pleasant	South Carolina
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	The Medical Research Network, LLC	New York	New York
United States	Pacific Research Partners; LLC.	Oakland	California
United States	Sarkis Clinical Trials	Ocala	Florida
United States	Paradigm Research Professionals	Oklahoma City	Oklahoma
United States	Red River Medical Research Center, LLC	Oklahoma City	Oklahoma
United States	Sooner Clinical Research, Inc	Oklahoma City	Oklahoma
United States	Millennium Psychiatric Associates	Olivette	Missouri
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Millenia Psychiatry & Research, Inc	Orlando	Florida
United States	Summit Research Network	Portland	Oregon
United States	Phoenix Medical Research	Prairie Village	Kansas
United States	Richard H. Weisler, MD, PA	Raleigh	North Carolina
United States	CITrials	Riverside	California
United States	CBH Health	Rockville	Maryland
United States	Woodland Research Northwest	Rogers	Arkansas
United States	PRA Health Sciences	Salt Lake City	Utah
United States	Artemis Institute for Clinical Research	San Diego	California
United States	PCSD Feighner Research	San Diego	California
United States	J Gary Booker, MD APMC	Shreveport	Louisiana
United States	IRIS Research	Smyrna	Georgia
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Family Psychiatry of The Wood	The Woodlands	Texas
United States	University of Arizona Department of Psychiatry	Tucson	Arizona
United States	Coastal Research Associates	Weymouth	Massachusetts
United States	Heartland Research Associates	Wichita	Kansas

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 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.	Baseline and 3 Weeks
Secondary	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.	Baseline and Day 8

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.