Clinical trial NCT03002077: Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
Official title: An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2016-12-23
Enrollment: 617
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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 β-human chorionic gonadotropin (β-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.

Primary outcomes:
measure: The Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+)
timeFrame: Baseline to 52 Weeks
measure: Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS)
timeFrame: Baseline to 52 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: Harmonex, Inc.
state: Alabama
city: Phoenix
country: United States
facility: NoesisPharma
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: Anaheim
country: United States
facility: California Pharmaceutical Research Institute, Inc
state: California
city: Beverly Hills
country: United States
facility: Southern California Research LLC.
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research, Inc
state: California
city: Lemon Grove
country: United States
facility: Synergy Clinical Research Center of Escondido
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Oakland
country: United States
facility: Pacific Research Partners; LLC.
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Panorama City
country: United States
facility: Asclepes Research Centers
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Riverside
country: United States
facility: CITrials
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: PCSD Feighner Research
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Center
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc
state: Florida
city: Miami
country: United States
facility: Innova Clinical Trials Inc.
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Orlando
country: United States
facility: Millenia Psychiatry & Research, Inc
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Psychiatry and Behavioral Neurosciences
state: Florida
city: Atlanta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Smyrna
country: United States
facility: Iris Research
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: AMR - Baber Research, Inc.
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Shreveport
country: United States
facility: J Gary Booker, MD APMC
state: Louisiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Baltimore
country: United States
facility: Pharmasite Research, Inc
state: Maryland
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc.
state: Massachusetts
city: South Weymouth
country: United States
facility: Coastal Research Associates
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical Trials
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Saint Louis
country: United States
facility: Millennium Psychiatric Associates
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Nashua
country: United States
facility: Healthy Perspectives - Innovative Mental Health Services. PLLC
state: New Hampshire
city: Berlin
country: United States
facility: Hassman Research Institute, LLC
state: New Jersey
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Marlton
country: United States
facility: Pharmaceutical Research Associates Inc
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institute, LLC
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc
state: New Mexico
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, Inc
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center, LLC
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: New York
country: United States
facility: Fieve Clinical Research
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: North Carolina
city: Charlotte
country: United States
facility: New Hope Clinical Research Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Richard H. Weisler, MD, PA
state: North Carolina
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Site, LLC
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Department of Psychiatry
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center LLC
state: Ohio
city: Garfield Heights
country: United States
facility: Charak Clinical Research Center
state: Ohio
city: Mason
country: United States
facility: Lindner Center of Hope
state: Ohio
city: Mason
country: United States
facility: Professional Psychiatric Services
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Red River Medical Research Center, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research, Inc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Norristown
country: United States
facility: Keystone Clinical Studies, LLC
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Tennessee
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC
state: Tennessee
city: Austin
country: United States
facility: Donald J. Garcia, Jr., MD, PA
state: Texas
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: El Campo
country: United States
facility: El Campo Clinical Trials
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: Houston
country: United States
facility: Earle Research
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Wood
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Salt Lake City
country: United States
facility: Psychiatric and Behavioral Solutions
state: Utah
city: Salt Lake City
country: United States
facility: Pharmaceutical Research Associates, Inc
state: Utah
city: Charlottesville
country: United States
facility: Psychiatric Alliance of the Blue Ridge, Inc.
state: Virginia
city: Bellevue
country: United States
facility: NorthWest Clinical Research Center
state: Washington
city: Bothell
country: United States
facility: Pacific Institute of Medical Sciences
state: Washington
Study officials:
affiliation: Allergan
name: Jenna Hoogerheyde
role: STUDY_DIRECTOR
References: