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

Primary Purpose

Depressive Disorder, Treatment-Resistant

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Esketamine 56 mg
Esketamine 84 mg
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (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 (example, medical/pharmacy/prescription records or a letter from a treating physician)
  • Participant must have an Inventory of Depressive Symptomatology-Clinician rated, 30-item (IDS-C30) total score of >=34
  • The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the State vs. Trait, Assessibility, Face Validity, Ecological Validity, Rule of Three P's (SAFER) Interview
  • Participant must be medically stable on the basis of physical examination, medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed in the screening phase. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, the determination of their clinical significance must be determined by the investigator and recorded in the participant's source documents and initiated by the investigator
  • Participant must be medically stable on the basis of clinical laboratory tests performed in the screening phase. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator: (a) Participants with a pre-existing history of thyroid disease/disorder who are treated with thyroid hormones must be on a stable dosage for 3 months prior to the start of the screening phase; (b) For any participant (regardless of thyroid history), if the thyroid-stimulating hormone (TSH) value is out of range, a free thyroxine (FT4) will be conducted. If the FT4 value is abnormal and considered to be clinically significant (after discussion with the medical monitor), the participant is not eligible
  • Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided

Exclusion Criteria:

  • The participant has used ketamine/esketamine (lifetime)
  • The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT
  • Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression
  • Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)
  • Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug

Sites / Locations

  • UAB Department of Psychiatry and Behavioral NeurobiologyRecruiting
  • UAB Huntsville Regional Medical CampusRecruiting
  • Preferred Research PartnersRecruiting
  • Behavioral Research Specialists, LLCRecruiting
  • CalNeuro ResearchRecruiting
  • Pacific Research Partners
  • Anderson Clinical ResearchRecruiting
  • University of California at San DiegoRecruiting
  • Artemis Institute for Clinical ResearchRecruiting
  • UCSF Nancy Friend Pritzker Psychiatry BuildingRecruiting
  • Velocity Clinical ResearchRecruiting
  • CMB Clinical TrialsRecruiting
  • University of Connecticut Health CenterRecruiting
  • Velocity Clinical Research, Hallandale Beach
  • Accel Research SitesRecruiting
  • APG Research, LLCRecruiting
  • USF, Department of Psychiatry and Behavioral NeurosciencesRecruiting
  • Neuroscience Research InstituteRecruiting
  • Atlanta Behavioral Research, LLCRecruiting
  • Psych Atlanta, P.C.Recruiting
  • Rush University Medical CenterRecruiting
  • Chicago Research CenterRecruiting
  • University of ChicagoRecruiting
  • Joliet Center for Clinical Research
  • Pillar Clinical Research, LLC
  • Psychiatric Medicine Associates LLCRecruiting
  • Ascension via Christi ResearchRecruiting
  • University of Kansas School of MedicineRecruiting
  • Sheppard Pratt Health SystemRecruiting
  • CBH HealthRecruiting
  • Copley ClinicalRecruiting
  • Adams ClinicalRecruiting
  • University of Massachusetts Medical SchoolRecruiting
  • University of Michigan
  • Rochester Center for Behavioral Medicine (RCBM)Recruiting
  • Midwest Research Group - St. Charles Psychiatric AssociatesRecruiting
  • Clinilabs
  • The Medical Research Network, LLCRecruiting
  • Stony Brook University Medical CenterRecruiting
  • Ohio State UniversityRecruiting
  • Midwest Clinical Research CenterRecruiting
  • Paradigm Research Professionals, LLCRecruiting
  • Lehigh Center for Clinical ResearchRecruiting
  • University of Pennsylvania Medical CenterRecruiting
  • The Warren Alpert Medical School of Brown University - Butler HospitalRecruiting
  • BioBehavioral Research of Austin, PCRecruiting
  • Relaro Medical TrialsRecruiting
  • University of Texas Southwestern Medical CenterRecruiting
  • Brain Health Consultants and TMS CenterRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Pillar Clinical Research, LLC
  • Family Psychiatry of The WoodlandsRecruiting
  • Grayline Research CenterRecruiting
  • University of Virginia Center for Psychiatric Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Esketamine 56 Milligram (mg)

Esketamine 84 mg

Placebo

Arm Description

Participants will receive nasal spray treatment with esketamine 56 mg twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 Montgomery-Asberg Depression Rating Scale [MADRS] assessment).

Participants will receive nasal spray treatment with esketamine 84 mg twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 MADRS assessment).

Participants will receive nasal spray treatment with placebo twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 MADRS assessment).

Outcomes

Primary Outcome Measures

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Day 1 (Pre-randomization) to the End of the 4-week Double-Blind Treatment Phase (Day 28)
MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Secondary Outcome Measures

Change from Baseline in MADRS Total Score from Day 1 (Pre-randomization) to Day 2
MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Full Information

First Posted
October 21, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04599855
Brief Title
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Official Title
A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
February 9, 2024 (Anticipated)
Study Completion Date
February 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression (TRD), as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Day 1 (prerandomization) to the end of the 4 week double-blind treatment phase (Day 28).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Treatment-Resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esketamine 56 Milligram (mg)
Arm Type
Experimental
Arm Description
Participants will receive nasal spray treatment with esketamine 56 mg twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 Montgomery-Asberg Depression Rating Scale [MADRS] assessment).
Arm Title
Esketamine 84 mg
Arm Type
Experimental
Arm Description
Participants will receive nasal spray treatment with esketamine 84 mg twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 MADRS assessment).
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive nasal spray treatment with placebo twice a week for 4 weeks. Participants may participate in an open-label treatment/observation phase, following completion of the double-blind treatment phase assessments (which includes the Day 28 MADRS assessment).
Intervention Type
Drug
Intervention Name(s)
Esketamine 56 mg
Other Intervention Name(s)
JNJ-54135419
Intervention Description
Esketamine 56 mg will be self administered as nasal spray.
Intervention Type
Drug
Intervention Name(s)
Esketamine 84 mg
Other Intervention Name(s)
JNJ-54135419
Intervention Description
Esketamine 84 mg will be self administered as nasal spray.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be self administered as nasal spray.
Primary Outcome Measure Information:
Title
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Day 1 (Pre-randomization) to the End of the 4-week Double-Blind Treatment Phase (Day 28)
Description
MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Time Frame
Baseline to Day 28
Secondary Outcome Measure Information:
Title
Change from Baseline in MADRS Total Score from Day 1 (Pre-randomization) to Day 2
Description
MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Time Frame
Baseline to Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (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 (example, medical/pharmacy/prescription records or a letter from a treating physician) Participant must have an Inventory of Depressive Symptomatology-Clinician rated, 30-item (IDS-C30) total score of >=34 The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the State vs. Trait, Assessibility, Face Validity, Ecological Validity, Rule of Three P's (SAFER) Interview Participant must be medically stable on the basis of physical examination, medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed in the screening phase. If there are any abnormalities that are not specified in the inclusion and exclusion criteria, the determination of their clinical significance must be determined by the investigator and recorded in the participant's source documents and initiated by the investigator Participant must be medically stable on the basis of clinical laboratory tests performed in the screening phase. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator: (a) Participants with a pre-existing history of thyroid disease/disorder who are treated with thyroid hormones must be on a stable dosage for 3 months prior to the start of the screening phase; (b) For any participant (regardless of thyroid history), if the thyroid-stimulating hormone (TSH) value is out of range, a free thyroxine (FT4) will be conducted. If the FT4 value is abnormal and considered to be clinically significant (after discussion with the medical monitor), the participant is not eligible Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided Exclusion Criteria: The participant has used ketamine/esketamine (lifetime) The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary) Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
UAB Department of Psychiatry and Behavioral Neurobiology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
UAB Huntsville Regional Medical Campus
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
CalNeuro Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Research Partners
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Individual Site Status
Completed
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8620
Country
United States
Individual Site Status
Recruiting
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF Nancy Friend Pritzker Psychiatry Building
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
91704
Country
United States
Individual Site Status
Recruiting
Facility Name
CMB Clinical Trials
City
Santee
State/Province
California
ZIP/Postal Code
92071
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Completed
Facility Name
Accel Research Sites
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Individual Site Status
Recruiting
Facility Name
APG Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
USF, Department of Psychiatry and Behavioral Neurosciences
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuroscience Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Behavioral Research, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Individual Site Status
Recruiting
Facility Name
Psych Atlanta, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Chicago Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Joliet Center for Clinical Research
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Individual Site Status
Completed
Facility Name
Pillar Clinical Research, LLC
City
Lincolnwood
State/Province
Illinois
ZIP/Postal Code
60712
Country
United States
Individual Site Status
Completed
Facility Name
Psychiatric Medicine Associates LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Name
CBH Health
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Name
Copley Clinical
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Individual Site Status
Recruiting
Facility Name
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Suspended
Facility Name
Rochester Center for Behavioral Medicine (RCBM)
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Research Group - St. Charles Psychiatric Associates
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinilabs
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Completed
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Recruiting
Facility Name
Paradigm Research Professionals, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Individual Site Status
Recruiting
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
The Warren Alpert Medical School of Brown University - Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Name
BioBehavioral Research of Austin, PC
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Relaro Medical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Individual Site Status
Recruiting
Facility Name
Brain Health Consultants and TMS Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77046
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
Pillar Clinical Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Completed
Facility Name
Family Psychiatry of The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Individual Site Status
Recruiting
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia Center for Psychiatric Clinical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Learn more about this trial

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

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