A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
1 other identifier
interventional
429
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2016
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedStudy Start
First participant enrolled
November 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2018
CompletedResults Posted
Study results publicly available
November 13, 2019
CompletedNovember 13, 2019
October 1, 2019
2 years
October 21, 2016
October 25, 2019
October 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change From Baseline in MADRS Total Score
Baseline and Day 8
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
Baseline and Day 21
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
Baseline and Day 8
Study Arms (2)
Rapastinel 450 mg
EXPERIMENTALRapastinel 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.
Placebo
PLACEBO COMPARATORPlacebo-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
NoesisPharma
Phoenix, Arizona, 85016, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Irvine Center for Clinical Research, Inc
Irvine, California, 92614, United States
NRC Research Institute
Orange, California, 92868, United States
Asclepes Research Centers
Panorama City, California, 91402, United States
Artemis Institute for Clinical Research
San Marcos, California, 92078, United States
MCB Clinical Research Center
Colorado Springs, Colorado, 80910, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Research Centers of America
Hollywood, Florida, 33024, United States
Innova Clinical Trials Inc.
Miami, Florida, 33133, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
Tampa, Florida, 33613, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
AMR - Baber Research, Inc.
Naperville, Illinois, 60563, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Louisiana Clinical Research
Shreveport, Louisiana, 71101, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21204, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304, United States
Alivation Research
Lincoln, Nebraska, 68526, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, 03060, United States
Hassman Research Institute, LLC
Berlin, New Jersey, 08009, United States
Global Medical Institute, LLC
Princeton, New Jersey, 08540, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Neuroscience, Inc
Albuquerque, New Mexico, 87109, United States
SPRI Clinical Trials, Inc
Brooklyn, New York, 11235, United States
Manhattan Behavioral Medicine
New York, New York, 10036, United States
Fieve Clinical Research
New York, New York, 10168, United States
New Hope Clinical Research Inc.
Charlotte, North Carolina, 28211, United States
Dr. Cherian Verghese
Norristown, Pennsylvania, 20006, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119, United States
Houston Clinical Trials, LLC
Bellaire, Texas, 77401, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Psychiatric and Behavioral Solutions
Salt Lake City, Utah, 84105, United States
Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
Charlottesville, Virginia, 22903, United States
Psychiatric Alliance of the Blue Ridge, Inc.
Charlottesville, Virginia, 22903, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Jenna Hoogerheyde
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2016
First Posted
October 24, 2016
Study Start
November 2, 2016
Primary Completion
October 26, 2018
Study Completion
November 21, 2018
Last Updated
November 13, 2019
Results First Posted
November 13, 2019
Record last verified: 2019-10