Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Depressive Disorder, Major Clinical Trial

Official title:

An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03668600
• Other study ID #: RAP-MD-99
• Status: Terminated
• Phase: Phase 3
• Start date: August 23, 2018
• Est. completion date: July 3, 2019

Study information

• Verified date: July 2020
• Source: Naurex, Inc, an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 230
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Rapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)

Locations

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	Institute for Advanced Medical Research	Atlanta	Georgia
United States	Community Clinical Research	Austin	Texas
United States	Donald J. Garcia, Jr., MD, PA	Austin	Texas
United States	Houston Clinical Trials	Bellaire	Texas
United States	Southern California Research LLC.	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	Psychiatric Alliance of the Blue Ridge, Inc	Charlottesville	Virginia
United States	Patient Priority Clinical Sites	Cincinnati	Ohio
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	Midwest Clinical Research Center LLC	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Harmonex Neuroscience Research	Dothan	Alabama
United States	Pharmacology Research Institute	Encino	California
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	Behavioral Research Specialists, LLC	Glendale	California
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	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Meridien Research	Lakeland	Florida
United States	Innovative Clinical Research, Inc	Lauderhill	Florida
United States	Synergy Clinical Research Center of Escondido	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	Professional Psychiatric Services	Mason	Ohio
United States	Research Strategies of Memphis, LLC	Memphis	Tennessee
United States	ActivMed Practices & Research, Inc.	Methuen	Massachusetts
United States	Coastal Carolina Research Center	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	Manhattan Behavioral Medicine	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	Research Centers of America	Oakland Park	Florida
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	Medical Research Group of Central Florida	Orange City	Florida
United States	David A. Medina, MD	Orlando	Florida
United States	NoesisPharma	Phoenix	Arizona
United States	Summit Research Network LLC	Portland	Oregon
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	Saint Charles	Missouri
United States	Psychiatric and Behavioral Solutions	Salt Lake City	Utah
United States	Clinical Trials of Texas	San Antonio	Texas
United States	California Neuroscience Research	Sherman Oaks	California
United States	Louisiana Clinical Research	Shreveport	Louisiana
United States	Attalla Consultants, LLC	Smyrna	Georgia
United States	Coastal Research Associates	South Weymouth	Massachusetts
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Viking Clinical Research	Temecula	California
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Pacific Clinical Research Medical	Upland	California
United States	University of Kansas School of Medicine Clinical Trial Unit	Wichita	Kansas
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Naurex, Inc, an affiliate of Allergan plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)	A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.	Up to 45 Weeks

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.