Clinical trial NCT02943577: A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in 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: 2016-10-24
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.


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 Visit 1
* 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 Visit 1
* Lifetime history of meeting DSM-5 criteria for:

  1. Schizophrenia spectrum or other psychotic disorder
  2. Bipolar or related disorder
  3. Major neurocognitive disorder
  4. 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
  5. Dissociative disorder
  6. Posttraumatic stress disorder
  7. MDD with psychotic features
* Significant suicide risk, as judged by the Investigator.

Primary outcomes:
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study
timeFrame: Baseline and 3 Weeks
Secondary outcomes:
measure: Change From Baseline in MADRS Total Score
timeFrame: Baseline and Day 8
measure: Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
timeFrame: Baseline and Day 21
measure: Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
timeFrame: Baseline and Day 8
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Phoenix
country: United States
facility: NoesisPharma
state: Arizona
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: Orange
country: United States
facility: NRC Research Institute
state: California
city: Panorama City
country: United States
facility: Asclepes Research Centers
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Center
state: Colorado
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Miami
country: United States
facility: Innova Clinical Trials Inc.
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida
state: Florida
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Naperville
country: United States
facility: AMR - Baber Research, Inc.
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
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: Lincoln
country: United States
facility: Alivation Research
state: Nebraska
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: 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: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: New York
country: United States
facility: Fieve Clinical Research
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research Inc.
state: North Carolina
city: Norristown
country: United States
facility: Dr. Cherian Verghese
state: Pennsylvania
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC
state: Tennessee
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
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: Department of Psychiatry and Neurobehavioral Sciences, University of Virginia
state: Virginia
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: