Depressive Disorder, Major Clinical Trial
Official title:
An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
| Verified date | June 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 long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
| Status | Completed |
| Enrollment | 617 |
| Est. completion date | December 6, 2018 |
| Est. primary completion date | December 6, 2018 |
| 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 | California Pharmaceutical Research Institute, Inc | Anaheim | California |
| United States | Atlanta Center for Medical Research | Atlanta | Georgia |
| United States | Institute for Advanced 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 | North Carolina |
| United States | New Hope Clinical Research Inc. | Charlotte | North Carolina |
| 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 | 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 | 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, Inc. | Dothan | Alabama |
| United States | El Campo Clinical Trials | El Campo | Texas |
| 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 | CBH Health | Gaithersburg | Maryland |
| 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 | 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 | Premier Psychiatric Research Institute, LLC | 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 | 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 | Keystone Clinical Studies, LLC | 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 | 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 | 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 | Woodland Research Northwest | Rogers | Arkansas |
| United States | St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri |
| United States | Millennium Psychiatric Associates | Saint Louis | Missouri |
| United States | Pharmaceutical Research Associates, Inc | 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 | Coastal Research Associates | South Weymouth | Massachusetts |
| United States | Richmond Behavioral Associates | Staten Island | New York |
| United States | Olympian Clinical Research | Tampa | Florida |
| United States | University of South Florida, Psychiatry and Behavioral Neurosciences | 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 | Pacific Clinical Research Medical | Upland | California |
| United States | Adams Clinical Trials | Watertown | 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 | The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | 52 Weeks | |
| Secondary | Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+) | The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement. | Baseline to 52 Weeks | |
| Secondary | Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS) | The Clinician Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences composed of 23 subjective self-reported and 5 objective observer-reported ratings, each scored from 0 (not at all) to 4 (extremely). Only the 23 subjective items will be collected and analyzed. The sum of each of the 23 subjective items was used for a total score of 0-92. A negative change from Baseline indicates improvement. | Baseline to 52 Weeks |
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