Clinical TrialTreatment-Resistant Depression (TRD)EsketamineEsketaminePlaceboCompleted

A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

Phase IV, double-blind, randomised, parallel-group trial (n=477) comparing esketamine nasal spray 56 mg and 84 mg versus placebo twice weekly for 4 weeks in adults with treatment-resistant depression, primary outcome change in MADRS from baseline to Day 28.

Target Enrollment
477 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group study evaluating efficacy of esketamine nasal spray 56 mg and 84 mg versus placebo in adults with treatment-resistant depression over a 4-week double-blind phase; primary endpoint is change in MADRS total score from baseline to Day 28.

Dosing consisted of intranasal self-administration twice weekly for 4 weeks (8 dosing sessions); study also included screening, safety assessments (vitals, ECG, labs), and option to enter an open-label treatment/observation phase after Day 28.

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

sessions

Study Arms & Interventions

Esketamine 56 mg

experimental

Esketamine nasal spray 56 mg, self-administered intranasal, twice weekly for 4 weeks.

Interventions

  • Esketamine56 mg
    via Other• twice a week• 8 doses total

    Intranasal self-administration; JNJ-54135419

Esketamine 84 mg

experimental

Esketamine nasal spray 84 mg, self-administered intranasal, twice weekly for 4 weeks.

Interventions

  • Esketamine84 mg
    via Other• twice a week• 8 doses total

    Intranasal self-administration; JNJ-54135419

Placebo

inactive

Matching placebo nasal spray, twice weekly for 4 weeks.

Interventions

  • Placebo
    via Other• twice a week• 8 doses total

    Matching placebo nasal spray

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Participant must meet the DSM-5 diagnostic criteria for single-episode MDD or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the MINI. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age.
  • Participant must have had nonresponse (<=25% improvement) to >=2 oral antidepressant treatments in the current episode of depression, assessed using the MGH-ATRQ, and confirmed by documented records.
  • Participant must have an IDS-C30 total score of >=34.
  • Current major depressive episode, symptom severity, and antidepressant treatment response must be confirmed by the SAFER Interview.
  • Participant must be medically stable by physical exam, medical history, vitals and 12-lead ECG; clinically significant abnormalities may exclude at investigator discretion.
  • Participant must be medically stable by clinical laboratory tests; thyroid status managed/stable as specified.
  • Participant must be comfortable with self-administration of nasal spray and able to follow administration instructions.

Exclusion Criteria

  • Lifetime use of ketamine/esketamine.
  • Nonresponse to an adequate course of ECT in the current episode (>=7 unilateral/bilateral treatments).
  • Prior VNS or DBS in the current episode of depression.
  • Current or history of seizures (except uncomplicated febrile childhood seizures).
  • Any anatomical or medical condition that may impede delivery or absorption of nasal spray as judged by investigator.

Study Details

Locations

UAB Department of Psychiatry and Behavioral Neurobiology — Birmingham, Alabama, United States
UAB Huntsville Regional Medical Campus — Huntsville, Alabama, United States
Preferred Research Partners — Little Rock, Arkansas, United States
Behavioral Research Specialists LLC — Glendale, California, United States
CalNeuro Research — Los Angeles, California, United States
Pacific Research Partners — Oakland, California, United States
Anderson Clinical Research — Redlands, California, United States
University of California at San Diego — San Diego, California, United States
Artemis Institute for Clinical Research — San Diego, California, United States
UCSF Nancy Friend Pritzker Psychiatry Building — San Francisco, California, United States
Velocity Clinical Research — Santa Ana, California, United States
CMB Clinical Trials — Santee, California, United States
University of Connecticut Health Center — Farmington, Connecticut, United States
Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States
Accel Research Sites — Lakeland, Florida, United States
APG Research LLC — Orlando, Florida, United States
USF, Department of Psychiatry and Behavioral Neurosciences — Tampa, Florida, United States
Neuroscience Research Institute — West Palm Beach, Florida, United States
Atlanta Behavioral Research, LLC — Atlanta, Georgia, United States
Psych Atlanta, P.C. — Marietta, Georgia, United States
Rush University Medical Center — Chicago, Illinois, United States
Chicago Research Center — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Joliet Center for Clinical Research — Joliet, Illinois, United States
Pillar Clinical Research, LLC — Lincolnwood, Illinois, United States
Psychiatric Medicine Associates LLC — Skokie, Illinois, United States
Ascension via Christi Research — Wichita, Kansas, United States
University of Kansas School of Medicine — Wichita, Kansas, United States
Sheppard Pratt Health System — Baltimore, Maryland, United States
CBH Health — Gaithersburg, Maryland, United States
Copley Clinical — Boston, Massachusetts, United States
Adams Clinical — Watertown, Massachusetts, United States
University of Massachusetts Medical School — Worcester, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Rochester Center for Behavioral Medicine (RCBM) — Rochester Hills, Michigan, United States
Midwest Research Group - St. Charles Psychiatric Associates — Saint Charles, Missouri, United States
Clinilabs — New York, New York, United States
The Medical Research Network, LLC — New York, New York, United States
Stony Brook University Medical Center — Stony Brook, New York, United States
Ohio State University — Columbus, Ohio, United States
Midwest Clinical Research Center — Dayton, Ohio, United States
Paradigm Research Professionals, LLC — Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research — Allentown, Pennsylvania, United States
University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
The Warren Alpert Medical School of Brown University - Butler Hospital — Providence, Rhode Island, United States
BioBehavioral Research of Austin PC — Austin, Texas, United States
Relaro Medical Trials — Dallas, Texas, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
Brain Health Consultants and TMS Center — Houston, Texas, United States
The University of Texas Health Science Center at Houston — Houston, Texas, United States
Pillar Clinical Research, LLC — Richardson, Texas, United States
Family Psychiatry of The Woodlands — The Woodlands, Texas, United States
Grayline Research Center — Wichita Falls, Texas, United States
University of Virginia Center for Psychiatric Clinical Research — Charlottesville, Virginia, United States

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