Study Stopped
Business decision to stop the program.
Study of Rapastinel as Monotherapy in Patients With MDD
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder
1 other identifier
interventional
439
1 country
40
Brief Summary
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).
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 Jun 2018
Shorter than P25 for phase_3
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
June 7, 2018
CompletedStudy Start
First participant enrolled
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2019
CompletedResults Posted
Study results publicly available
September 1, 2020
CompletedSeptember 1, 2020
August 1, 2020
1.1 years
June 7, 2018
July 7, 2020
August 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6)
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 a 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 to end of Week 6
Secondary Outcomes (1)
Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment
Baseline to Day 1 post-first dose
Study Arms (3)
Rapastinel 450mg
EXPERIMENTALRapastinel 450 mg (prefilled syringe, weekly intravenous IV administration)
Rapastinel 900mg
EXPERIMENTALRapastinel 900 mg (prefilled syringe, weekly intravenous IV administration)
Placebo
PLACEBO COMPARATORPlacebo (prefilled syringe, weekly IV administration)
Interventions
Rapastinel (prefilled syringe, weekly intravenous IV administration)
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
- Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
- 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)
Alea Research
Phoenix, Arizona, 85012, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
California Pharmaceutical Research Institute, Inc.
Anaheim, California, 92804, United States
Collaborative Neuroscience Network
Garden Grove, California, 92845, United States
Synergy Research San Diego
National City, California, 91950, United States
Excell Research Inc.
Oceanside, California, 92056, United States
NRC Research Institute
Orange, California, 92868, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
California Neuroscience Research Medical Group,Inc.
Sherman Oaks, California, 91403, United States
Viking Clinical Research Ltd.
Temecula, California, 92591, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Research Centers of America, LLC
Hollywood, Florida, 33024, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Innova Clinical Trials
Miami, Florida, 33133, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Institute for Advanced Medical Research
Atlanta, Georgia, 30341, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Iris Research, Inc.
Smyrna, Georgia, 30082, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
CBH Health, LLC
Gaithersburg, Maryland, 20877, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Adams Clinical
Watertown, Massachusetts, 02472, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Bioscience Research LLC
Mount Kisco, New York, 10549, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10028, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, 10128, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
New Hope Clinical Research Inc.
Charlotte, North Carolina, 28211, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403, United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, 78737, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to study termination, the target number of participants needed to achieve target power and statistically reliable results was not met.
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2018
First Posted
June 18, 2018
Study Start
June 15, 2018
Primary Completion
July 8, 2019
Study Completion
July 8, 2019
Last Updated
September 1, 2020
Results First Posted
September 1, 2020
Record last verified: 2020-08