Study Stopped
Business decision to stop the program.
Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)
A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder
2 other identifiers
interventional
363
5 countries
52
Brief Summary
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse 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 Aug 2018
Shorter than P25 for phase_3
52 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
July 30, 2018
CompletedStudy Start
First participant enrolled
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2019
CompletedResults Posted
Study results publicly available
October 9, 2020
CompletedOctober 9, 2020
September 1, 2020
11 months
July 30, 2018
July 10, 2020
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
52 Weeks
Study Arms (3)
Rapastinel weekly
EXPERIMENTALRapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
Rapastinel clinically driven schedule
EXPERIMENTALRapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Placebo weekly
PLACEBO COMPARATORPlacebo (prefilled syringe, weekly IV administration)
Interventions
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Eligibility Criteria
You may qualify if:
- Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
- 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 (52)
Alea Research
Phoenix, Arizona, 85012, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
California Pharmaceutical Research Institute
Anaheim, California, 92804, 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
Hollywood, Florida, 33024, United States
Clinical NeuroscienceSolutions, 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
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
CBH Health
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
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
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
Bugát Pál Hospital, Clinexpert
Gyöngyös, 3200, Hungary
Medical corporation Sato-Kai Yuge Hospital
Kumamoto, 861-8002, Japan
Sagaarashiyama-Tanaka Clinic
Kyoto, 616-8421, Japan
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku, 154-0004, Japan
Yoyogi Mental Clinic
Shibuya-ku, 151-0051, Japan
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053, Japan
Ohwa Mental Clinic
Toshima-ku, 170-0002, Japan
Centrum Medyczne Luxmed Sp.z o.o.
Lublin, 20-109, Poland
VAVRUŠOVÁ CONSULTING s.r.o., Psychiatrická ambulancia
Bratislava, 851 01, Slovakia
MENTUM, s.r.o.
Bratislava Mestská Časť Ružinov, 820 07, Slovakia
Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
Liptovský Mikuláš, 031 23, Slovakia
PsychoLine s.r.o., Psychiatrická ambulancia
Rimavská Sobota, 979 01, Slovakia
Related Links
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
July 30, 2018
First Posted
August 3, 2018
Study Start
August 2, 2018
Primary Completion
July 11, 2019
Study Completion
July 11, 2019
Last Updated
October 9, 2020
Results First Posted
October 9, 2020
Record last verified: 2020-09