Clinical trial NCT03352453: A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2017-11-24
Enrollment: 138
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: The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.


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 4 weeks and not exceeding 24 months in duration at visit 1
* Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
* 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 1 month before Visit 1.
* Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
* Prior participation in any investigational study of rapastinel/GLYX-13

Primary outcomes:
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and 1 Day
measure: Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
timeFrame: Baseline and 1 Day
Secondary outcomes:
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and 28 Days
measure: Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score
timeFrame: Baseline and 28 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
state: Alabama
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: Panorama City
country: United States
facility: Asclepes Research Centers
state: California
city: Hartford
country: United States
facility: Institute of Living
state: Connecticut
city: Hialeah
country: United States
facility: Innovative Clinical Research, Inc
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research (ACMR)
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Richardson
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Roanoke
country: United States
facility: Carilion Medical Center, a Virginia Nonprofit Corporation
state: Virginia
city: Salem
country: United States
facility: Department of Veterans Affairs Salem VA Medical Center
state: Virginia
Study officials:
affiliation: Allergan
name: Jenna Hoogerheyde
role: STUDY_DIRECTOR
References: