A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
- Registration Number
- NCT02943577
- Lead Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 429
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment. Rapastinel 450 mg Rapastinel Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
- Primary Outcome Measures
Name Time Method Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study Baseline and 3 Weeks 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in MADRS Total Score Baseline and Day 8 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.
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population Baseline and Day 8 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.
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population Baseline and Day 21 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.
Trial Locations
- Locations (40)
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Innova Clinical Trials Inc.
🇺🇸Miami, Florida, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States
Irvine Center for Clinical Research, Inc
🇺🇸Irvine, California, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Asclepes Research Centers
🇺🇸Panorama City, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
AMR - Baber Research, Inc.
🇺🇸Naperville, Illinois, United States
Sheppard Pratt Health System
🇺🇸Baltimore, Maryland, United States
Psychiatric Care and Research Center
🇺🇸O'Fallon, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Albuquerque Neuroscience, Inc
🇺🇸Albuquerque, New Mexico, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
SPRI Clinical Trials, Inc
🇺🇸Brooklyn, New York, United States
Dr. Cherian Verghese
🇺🇸Norristown, Pennsylvania, United States
Fieve Clinical Research
🇺🇸New York, New York, United States
New Hope Clinical Research Inc.
🇺🇸Charlotte, North Carolina, United States
Research Strategies of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Houston Clinical Trials, LLC
🇺🇸Bellaire, Texas, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, 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
Psychiatric and Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
MCB Clinical Research Center
🇺🇸Colorado Springs, Colorado, United States
Louisiana Clinical Research
🇺🇸Shreveport, Louisiana, United States
Hassman Research Institute, LLC
🇺🇸Berlin, New Jersey, United States
Global Medical Institute, LLC
🇺🇸Princeton, New Jersey, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
🇺🇸Nashua, New Hampshire, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, 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
NoesisPharma
🇺🇸Phoenix, Arizona, United States
Combined Research Orlando Phase I-IV
🇺🇸Orlando, Florida, United States
Alivation Research
🇺🇸Lincoln, Nebraska, United States