A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
1 other identifier
interventional
465
1 country
31
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.
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 Oct 2016
31 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 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedStudy Start
First participant enrolled
October 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2018
CompletedResults Posted
Study results publicly available
October 11, 2019
CompletedOctober 11, 2019
September 1, 2019
1.9 years
October 12, 2016
September 21, 2019
September 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial
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 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.
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 stess disorder
- MDD with psychotic features
- Significant suicide risk, as judged by the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Southern California Research LLC.
Beverly Hills, California, 90036, United States
ATP Clinical Research Inc.
Costa Mesa, California, 92626, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Excell Research
Oceanside, California, 92056, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
Sherman Oaks, California, 91403, United States
Viking Clinical Research
Temecula, California, 92591, United States
Pacific Clinical Research Medical
Upland, California, 91786, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Meridien Research
Bradenton, Florida, 34201, United States
MD Clinical
Hallandale, Florida, 33009, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Meridien Research
Lakeland, Florida, 33805, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Adams Clinical Trials
Watertown, Massachusetts, 02472, United States
Altea Research
Las Vegas, Nevada, 89102, United States
Bioscience Research
Mount Kisco, New York, 10549, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, 10128, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Midwest Clinical Research Center LLC
Dayton, Ohio, 45417, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119, United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, 78737, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
NorthWest Clinical Research Center
Bellevue, Washington, 98007, 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 12, 2016
First Posted
October 13, 2016
Study Start
October 15, 2016
Primary Completion
September 21, 2018
Study Completion
November 8, 2018
Last Updated
October 11, 2019
Results First Posted
October 11, 2019
Record last verified: 2019-09