Clinical trial NCT03668600: Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
Official title: An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Depression
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.


Eligibility criteria: Inclusion Criteria:

* Completion of lead-in study
* Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

Exclusion Criteria:

* Suicide risk, as determined by meeting any of the following criteria:

  1. A suicide attempt within the past year
  2. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
  3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.
* At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
* Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation
* Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception

Primary outcomes:
measure: Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 45 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
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: Encino
country: United States
facility: Pharmacology Research Institute
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: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Riverside
country: United States
facility: CITrials
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
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: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research
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: 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: David A. Medina, MD
state: Florida
city: Atlanta
country: United States
facility: Institute for Advanced 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: Attalla Consultants, LLC
state: Georgia
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: Wichita
country: United States
facility: University of Kansas School of Medicine Clinical Trial Unit
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: Methuen
country: United States
facility: ActivMed Practices & Research, Inc.
state: Massachusetts
city: South Weymouth
country: United States
facility: Coastal Research Associates
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
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Nashua
country: United States
facility: Healthy Perspectives - Innovative Mental Health Services. PLLC
state: New Hampshire
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, LLC
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
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: Cincinnati
country: United States
facility: Patient Priority Clinical Sites
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: Mason
country: United States
facility: Professional Psychiatric Services
state: Ohio
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 LLC
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Norristown
country: United States
facility: Dr. Cherian Verghese
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
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
state: Texas
city: Bellaire
country: United States
facility: Houston 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: 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: Charlottesville
country: United States
facility: Psychiatric Alliance of the Blue Ridge, Inc
state: Virginia
Study officials:
affiliation: Allergan
name: Jenna Hoogerheyde
role: STUDY_DIRECTOR
References: