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

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: NCT02943577
• Other study ID #: RAP-MD-03
• Status: Completed
• Phase: Phase 3
• Start date: November 2, 2016
• Est. completion date: November 21, 2018

Study information

• Verified date: October 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: November 21, 2018
• Est. primary completion date: October 26, 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
• Disease

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	Albuquerque Neuroscience, Inc	Albuquerque	New Mexico
United States	Sheppard Pratt Health System	Baltimore	Maryland
United States	Houston Clinical Trials, LLC	Bellaire	Texas
United States	Hassman Research Institute, LLC	Berlin	New Jersey
United States	SPRI Clinical Trials, Inc	Brooklyn	New York
United States	New Hope Clinical Research Inc.	Charlotte	North Carolina
United States	Department of Psychiatry and Neurobehavioral Sciences, University of Virginia	Charlottesville	Virginia
United States	Psychiatric Alliance of the Blue Ridge, Inc.	Charlottesville	Virginia
United States	MCB Clinical Research Center	Colorado Springs	Colorado
United States	Harmonex Neuroscience Research	Dothan	Alabama
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	North Texas Clinical Trials	Fort Worth	Texas
United States	Research Centers of America	Hollywood	Florida
United States	Sun Valley Research Center	Imperial	California
United States	Irvine Center for Clinical Research, Inc	Irvine	California
United States	Alivation Research	Lincoln	Nebraska
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Research Strategies of Memphis, LLC	Memphis	Tennessee
United States	Innova Clinical Trials Inc.	Miami	Florida
United States	AMR - Baber Research, Inc.	Naperville	Illinois
United States	Healthy Perspectives - Innovative Mental Health Services. PLLC	Nashua	New Hampshire
United States	Fieve Clinical Research	New York	New York
United States	Manhattan Behavioral Medicine	New York	New York
United States	Dr. Cherian Verghese	Norristown	Pennsylvania
United States	Psychiatric Care and Research Center	O'Fallon	Missouri
United States	NRC Research Institute	Orange	California
United States	Combined Research Orlando Phase I-IV	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Asclepes Research Centers	Panorama City	California
United States	NoesisPharma	Phoenix	Arizona
United States	Global Medical Institute, LLC	Princeton	New Jersey
United States	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri
United States	Psychiatric and Behavioral Solutions	Salt Lake City	Utah
United States	Artemis Institute for Clinical Research	San Marcos	California
United States	Louisiana Clinical Research	Shreveport	Louisiana
United States	Olympian Clinical Research	Tampa	Florida
United States	The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	University of Massachusetts Medical School	Worcester	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 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
Secondary	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.	Baseline and Day 21
Secondary	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.	Baseline and Day 8

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