Depressive Disorder, Major Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
| Verified date | February 2020 |
| Source | Naurex, Inc, an affiliate of Allergan plc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD).
| Status | Completed |
| Enrollment | 1304 |
| Est. completion date | February 22, 2019 |
| Est. primary completion date | February 22, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Screening - 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 ß-human chorionic gonadotropin (ß-hCG) pregnancy test. Exclusion Criteria: - DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albuquerque Neuroscience, Inc | Albuquerque | New Mexico |
| United States | Lehigh Center for Clinical Research | Allentown | Pennsylvania |
| United States | Institute for Advanced Medical Research | Alpharetta | Georgia |
| United States | California Pharmaceutical Research Institute, Inc | Anaheim | California |
| United States | Atlanta Center for Medical Research | Atlanta | Georgia |
| United States | BioBehavioral Research of Austin | Austin | Texas |
| United States | Community Clinical Research, Inc. | Austin | Texas |
| United States | Donald J. Garcia, Jr., MD, PA | Austin | Texas |
| United States | Pharmasite Research, Inc | Baltimore | Maryland |
| United States | Sheppard Pratt Health System | Baltimore | Maryland |
| United States | Houston Clinical Trials, LLC | Bellaire | Texas |
| United States | NorthWest Clinical Research Center | Bellevue | Washington |
| United States | Hassman Research Institute, LLC | Berlin | New Jersey |
| United States | Southern California Research LLC. | Beverly Hills | California |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Boston Clinical Trials | Boston | Massachusetts |
| United States | Pacific Institute of Medical Sciences | Bothell | Washington |
| United States | Meridien Research | Bradenton | Florida |
| United States | SPRI Clinical Trials, Inc | Brooklyn | New York |
| United States | Neuro-Behavioral Clinical Research, Inc | Canton | Ohio |
| United States | Carolina Clinical Trials, Inc. | Charleston | South Carolina |
| United States | New Hope Clinical Research Inc. | Charlotte | North Carolina |
| United States | Department of Psychiatry and Neurobehavioral Sciences, University of Virginia | Charlottesville | Virginia |
| United States | Psychiatric Alliance of the Blue Ridge, Inc | Charlottesville | Virginia |
| United States | Center for Emotional Fitness | Cherry Hill | New Jersey |
| United States | Great Lakes Clinical Trials | Chicago | Illinois |
| United States | Patient Priority Clinical Site, LLC | Cincinnati | Ohio |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | MCB Clinical Research Center | Colorado Springs | Colorado |
| United States | The Ohio State University Department of Psychiatry | Columbus | Ohio |
| United States | ATP Clinical Research Inc. | Costa Mesa | California |
| United States | Millennium Psychiatric Associates | Creve Coeur | Missouri |
| United States | ProScience Research Group | Culver City | California |
| United States | Relaro Medical Trials | Dallas | Texas |
| United States | Midwest Clinical Research Center LLC | Dayton | Ohio |
| United States | iResearch Atlanta, LLC | Decatur | Georgia |
| United States | Harmonex Neuroscience Research | Dothan | Alabama |
| United States | El Campo Clinical Trials | El Campo | Texas |
| United States | Pharmacology Research Institute | Encino | California |
| United States | Eastside Therapeutic Resource | Everett | Washington |
| United States | Precise Research Centers | Flowood | Mississippi |
| United States | Gulfcoast Clinical Research Center | Fort Myers | Florida |
| United States | North Texas Clinical Trials | Fort Worth | Texas |
| United States | Sarkis Clinical Trials | Gainesville | Florida |
| United States | Collaborative Neuroscience Network, LLC | Garden Grove | California |
| United States | Charak Clinical Research Center | Garfield Heights | Ohio |
| United States | Behavioral Research Specialists, LLC | Glendale | California |
| United States | MD Clinical | Hallandale Beach | Florida |
| United States | Reliable Clinical Research | Hialeah | Florida |
| United States | Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois |
| United States | Advanced Research Institute of Miami | Homestead | Florida |
| United States | Earle Research | Houston | Texas |
| United States | Red Oak Psychiatry Associates, PA | Houston | Texas |
| United States | Sun Valley Research Center | Imperial | California |
| United States | Irvine Center for Clinical Research, Inc | Irvine | California |
| United States | Clinical Neuroscience Solutions, Inc | Jacksonville | Florida |
| United States | Lake Charles Clinical Trials | Lake Charles | Louisiana |
| United States | Meridien Research | Lakeland | Florida |
| United States | Altea Research | Las Vegas | Nevada |
| United States | Innovative Clinical Research, Inc | Lauderhill | Florida |
| United States | Synergy Clinical Research Center of Escondido | Lemon Grove | California |
| United States | Synergy San Diego | Lemon Grove | California |
| United States | Capstone Clinical Research | Libertyville | Illinois |
| United States | Alivation Research | Lincoln | Nebraska |
| United States | Woodland International Research Group | Little Rock | Arkansas |
| United States | Pharmacology Research Institute | Los Alamitos | California |
| United States | Northwest Behavioral Research Center | Marietta | Georgia |
| United States | Pharmaceutical Research Associates Inc | Marlton | New Jersey |
| United States | Lindner Center of Hope | Mason | Ohio |
| United States | Professional Psychiatric Services | Mason | Ohio |
| United States | Suburban Research Associates | Media | Pennsylvania |
| United States | Clinical Neuroscience Solutions, Inc | Memphis | Tennessee |
| United States | Research Strategies of Memphis, LLC | Memphis | Tennessee |
| United States | ActivMed Practices & Research, Inc. | Methuen | Massachusetts |
| United States | Innova Clinical Trials Inc. | Miami | Florida |
| United States | International Research Associates, LLC | Miami | Florida |
| United States | Bioscience Research | Mount Kisco | New York |
| United States | Coastal Carolina Research Center, Inc. | Mount Pleasant | South Carolina |
| United States | AMR - Baber Research, Inc. | Naperville | Illinois |
| United States | Healthy Perspectives - Innovative Mental Health Services. PLLC | Nashua | New Hampshire |
| United States | BTC of New Bedford | New Bedford | Massachusetts |
| United States | Eastside Comprehensive Medical Center, LLC | New York | New York |
| United States | Fieve Clinical Research | New York | New York |
| United States | Manhattan Behavioral Medicine | New York | New York |
| United States | The Medical Research Network, LLC | New York | New York |
| United States | Dr. Cherian Verghese | Norristown | Pennsylvania |
| United States | Comprehensive Psychiatric Care | Norwich | Connecticut |
| United States | Psychiatric Care and Research Center | O'Fallon | Missouri |
| United States | Pacific Research Partners; LLC. | Oakland | California |
| United States | Research Centers of America | Oakland Park | Florida |
| United States | Sarkis Clinical Trials | Ocala | Florida |
| United States | Excell Research | Oceanside | California |
| United States | IPS Research | Oklahoma City | Oklahoma |
| United States | Paradigm Research Professionals | Oklahoma City | Oklahoma |
| United States | Red River Medical Research Center, LLC | Oklahoma City | Oklahoma |
| United States | Sooner Clinical Research, Inc | Oklahoma City | Oklahoma |
| United States | NRC Research Institute | Orange | California |
| United States | Medical Research Group of Central Florida | Orange City | Florida |
| United States | Clinical Neuroscience Solutions, Inc | Orlando | Florida |
| United States | Combined Research Orlando Phase I-IV | Orlando | Florida |
| United States | Millenia Psychiatry & Research, Inc | Orlando | Florida |
| United States | Psychiatric Associates | Overland Park | Kansas |
| United States | Asclepes Research Centers | Panorama City | California |
| United States | NoesisPharma | Phoenix | Arizona |
| United States | Summit Research Network | Portland | Oregon |
| United States | Phoenix Medical Research | Prairie Village | Kansas |
| United States | Global Medical Institute, LLC | Princeton | New Jersey |
| United States | Richard H. Weisler, MD, PA | Raleigh | North Carolina |
| United States | Anderson Clinical Research | Redlands | California |
| United States | CITrials | Riverside | California |
| United States | Finger Lakes Clinical Research | Rochester | New York |
| United States | CBH Health | Rockville | Maryland |
| United States | Woodland Research Northwest | Rogers | Arkansas |
| United States | St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri |
| United States | PRA Health Sciences | Salt Lake City | Utah |
| United States | Psychiatric and Behavioral Solutions | Salt Lake City | Utah |
| United States | Clinical Trials of Texas | San Antonio | Texas |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | PCSD Feighner Research | San Diego | California |
| United States | Artemis Institute for Clinical Research | San Marcos | California |
| United States | Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc., | Sherman Oaks | California |
| United States | J Gary Booker, MD APMC | Shreveport | Louisiana |
| United States | Louisiana Clinical Research | Shreveport | Louisiana |
| United States | IRIS Research | Smyrna | Georgia |
| United States | Richmond Behavioral Associates | Staten Island | New York |
| United States | Olympian Clinical Research | Tampa | Florida |
| United States | The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida | Tampa | Florida |
| United States | Viking Clinical Research | Temecula | California |
| United States | Family Psychiatry of The Wood | The Woodlands | Texas |
| United States | Bio Behavioral Health | Toms River | New Jersey |
| United States | University of Arizona Department of Psychiatry | Tucson | Arizona |
| United States | Pacific Clinical Research Medical | Upland | California |
| United States | Adams Clinical Trials | Watertown | Massachusetts |
| United States | Coastal Research Associates | Weymouth | Massachusetts |
| United States | Heartland Research Associates | Wichita | Kansas |
| United States | Grayline Clinical Drug Trials | Wichita Falls | Texas |
| United States | University of Massachusetts Medical School | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Naurex, Inc, an affiliate of Allergan plc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period | 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 | |
| Primary | Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales | On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent" |
104 Weeks | |
| Secondary | Time to First Relapse During the Entire Double-Blind Treatment Period | The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse. | 104 Weeks |
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