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

PHASE4CompletedINTERVENTIONAL
Enrollment

477

Participants

Timeline

Start Date

November 4, 2020

Primary Completion Date

January 31, 2024

Study Completion Date

January 31, 2024

Conditions
Depressive Disorder, Treatment-Resistant
Interventions
DRUG

Esketamine 56 mg

Esketamine 56 mg will be self administered as nasal spray.

DRUG

Esketamine 84 mg

Esketamine 84 mg will be self administered as nasal spray.

DRUG

Placebo

Matching placebo will be self administered as nasal spray.

Trial Locations (54)

10016

Clinilabs, New York

10128

The Medical Research Network, LLC, New York

11794

Stony Brook University Medical Center, Stony Brook

18104

Lehigh Center for Clinical Research, Allentown

19104

University of Pennsylvania Medical Center, Philadelphia

20877

CBH Health, Gaithersburg

21204

Sheppard Pratt Health System, Baltimore

22903

University of Virginia Center for Psychiatric Clinical Research, Charlottesville

30060

Psych Atlanta, P.C., Marietta

30338

Atlanta Behavioral Research, LLC, Atlanta

32803

APG Research LLC, Orlando

33009

Velocity Clinical Research, Hallandale Beach, Hallandale

33407

Neuroscience Research Institute, West Palm Beach

33613

USF, Department of Psychiatry and Behavioral Neurosciences, Tampa

33803

Accel Research Sites, Lakeland

35294

UAB Department of Psychiatry and Behavioral Neurobiology, Birmingham

35801

UAB Huntsville Regional Medical Campus, Huntsville

43210

Ohio State University, Columbus

45417

Midwest Clinical Research Center, Dayton

48109

University of Michigan, Ann Arbor

48307

Rochester Center for Behavioral Medicine (RCBM), Rochester Hills

60076

Psychiatric Medicine Associates LLC, Skokie

60435

Joliet Center for Clinical Research, Joliet

60612

Rush University Medical Center, Chicago

60634

Chicago Research Center, Chicago

60637

University of Chicago, Chicago

60712

Pillar Clinical Research, LLC, Lincolnwood

63304

Midwest Research Group - St. Charles Psychiatric Associates, Saint Charles

67214

Ascension via Christi Research, Wichita

University of Kansas School of Medicine, Wichita

72211

Preferred Research Partners, Little Rock

73118

Paradigm Research Professionals, LLC, Oklahoma City

75080

Pillar Clinical Research, LLC, Richardson

75243

Relaro Medical Trials, Dallas

75247

University of Texas Southwestern Medical Center, Dallas

76309

Grayline Research Center, Wichita Falls

77046

Brain Health Consultants and TMS Center, Houston

77054

The University of Texas Health Science Center at Houston, Houston

77381

Family Psychiatry of The Woodlands, The Woodlands

78759

BioBehavioral Research of Austin PC, Austin

90025

CalNeuro Research, Los Angeles

91206

Behavioral Research Specialists LLC, Glendale

91704

Velocity Clinical Research, Santa Ana

92071

CMB Clinical Trials, Santee

92103

Artemis Institute for Clinical Research, San Diego

92374

Anderson Clinical Research, Redlands

94143

UCSF Nancy Friend Pritzker Psychiatry Building, San Francisco

94607

Pacific Research Partners, Oakland

92103-8620

University of California at San Diego, San Diego

06032

University of Connecticut Health Center, Farmington

02116

Copley Clinical, Boston

02472

Adams Clinical, Watertown

01655

University of Massachusetts Medical School, Worcester

02906

The Warren Alpert Medical School of Brown University - Butler Hospital, Providence

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT04599855 - A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression | Biotech Hunter | Biotech Hunter