Clinical trial NCT02943564: A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)
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: 658
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 two doses of rapastinel, 225 milligrams (mg) and 450 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Department of Psychiatry
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: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy Clinical Research Center of Escondido
state: California
city: Oakland
country: United States
facility: Pacific Research Partners; LLC.
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: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Ocala
country: United States
facility: Sarkis Clinical Trials
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: Millenia Psychiatry & Research, Inc
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
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: Prairie Village
country: United States
facility: Phoenix Medical Research
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: J Gary Booker, MD APMC
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc
state: Maryland
city: Rockville
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: New Bedford
country: United States
facility: BTC of New Bedford
state: Massachusetts
city: Weymouth
country: United States
facility: Coastal Research Associates
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Olivette
country: United States
facility: Millennium Psychiatric Associates
state: Missouri
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: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Raleigh
country: United States
facility: Richard H. Weisler, MD, PA
state: North Carolina
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: 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: 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: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
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: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: El Campo
country: United States
facility: El Campo 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: The Woodlands
country: United States
facility: Family Psychiatry of The Wood
state: Texas
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
city: Bothell
country: United States
facility: Pacific Institute of Medical Sciences
state: Washington
city: Everett
country: United States
facility: Eastside Therapeutic Resource
state: Washington
Study officials:
affiliation: Allergan
name: Jenna Hoogerheyde
role: STUDY_DIRECTOR
References: