A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
- Registration Number
- NCT02932943
- Lead Sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Brief Summary
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 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
- 465
- 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 stess 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 milligram (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 Trial 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 (28)
Southern California Research LLC.
🇺🇸Beverly Hills, California, United States
ATP Clinical Research Inc.
🇺🇸Costa Mesa, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸Garden Grove, California, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Excell Research
🇺🇸Oceanside, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
🇺🇸Sherman Oaks, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Viking Clinical Research
🇺🇸Temecula, California, United States
Pacific Clinical Research Medical
🇺🇸Upland, California, United States
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Bioscience Research
🇺🇸Mount Kisco, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Eastside Comprehensive Medical Center, LLC
🇺🇸New York, New York, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
Midwest Clinical Research Center LLC
🇺🇸Dayton, Ohio, United States
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
Donald J. Garcia, Jr., MD, PA
🇺🇸Austin, Texas, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
NorthWest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Meridien Research
🇺🇸Lakeland, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Memphis, Tennessee, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Altea Research
🇺🇸Las Vegas, Nevada, United States
Adams Clinical Trials
🇺🇸Watertown, Massachusetts, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States