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CompletedNCT04599855

Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered for treatment-resistant depression

This study is completed in the United States. It is testing efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered for treatment-resistant depression.

DepressionDrugOver 18 Years

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  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

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Study start dateStarted: November 4, 2020
Recruitment status
Completed
Enrollment listed in the registry
477
Sponsor
Janssen Research & Development, LLC
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
Locations
United States
Age range
Over 18 Years
Official registry ID
NCT04599855
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

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

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The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

United States · 54 sites
  • UAB Department of Psychiatry and Behavioral Neurobiology
    Birmingham, Alabama
    Site status: Not listed — confirm with the team
  • UAB Huntsville Regional Medical Campus
    Huntsville, Alabama
    Site status: Not listed — confirm with the team
  • Preferred Research Partners
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Behavioral Research Specialists LLC
    Glendale, California
    Site status: Not listed — confirm with the team
  • CalNeuro Research
    Los Angeles, California
    Site status: Not listed — confirm with the team
  • Pacific Research Partners
    Oakland, California
    Site status: Not listed — confirm with the team
  • Anderson Clinical Research
    Redlands, California
    Site status: Not listed — confirm with the team
  • University of California at San Diego
    San Diego, California
    Site status: Not listed — confirm with the team
  • Artemis Institute for Clinical Research
    San Diego, California
    Site status: Not listed — confirm with the team
  • UCSF Nancy Friend Pritzker Psychiatry Building
    San Francisco, California
    Site status: Not listed — confirm with the team
  • Velocity Clinical Research
    Santa Ana, California
    Site status: Not listed — confirm with the team
  • CMB Clinical Trials
    Santee, California
    Site status: Not listed — confirm with the team
  • University of Connecticut Health Center
    Farmington, Connecticut
    Site status: Not listed — confirm with the team
  • Velocity Clinical Research, Hallandale Beach
    Hallandale, Florida
    Site status: Not listed — confirm with the team
  • Accel Research Sites
    Lakeland, Florida
    Site status: Not listed — confirm with the team
  • APG Research LLC
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • USF, Department of Psychiatry and Behavioral Neurosciences
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • Neuroscience Research Institute
    West Palm Beach, Florida
    Site status: Not listed — confirm with the team
  • Atlanta Behavioral Research, LLC
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Psych Atlanta, P.C.
    Marietta, Georgia
    Site status: Not listed — confirm with the team
  • Rush University Medical Center
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Chicago Research Center
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • University of Chicago
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Joliet Center for Clinical Research
    Joliet, Illinois
    Site status: Not listed — confirm with the team
  • Pillar Clinical Research, LLC
    Lincolnwood, Illinois
    Site status: Not listed — confirm with the team
  • Psychiatric Medicine Associates LLC
    Skokie, Illinois
    Site status: Not listed — confirm with the team
  • Ascension via Christi Research
    Wichita, Kansas
    Site status: Not listed — confirm with the team
  • University of Kansas School of Medicine
    Wichita, Kansas
    Site status: Not listed — confirm with the team
  • Sheppard Pratt Health System
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • CBH Health
    Gaithersburg, Maryland
    Site status: Not listed — confirm with the team
  • Copley Clinical
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Adams Clinical
    Watertown, Massachusetts
    Site status: Not listed — confirm with the team
  • University of Massachusetts Medical School
    Worcester, Massachusetts
    Site status: Not listed — confirm with the team
  • University of Michigan
    Ann Arbor, Michigan
    Site status: Not listed — confirm with the team
  • Rochester Center for Behavioral Medicine (RCBM)
    Rochester Hills, Michigan
    Site status: Not listed — confirm with the team
  • Midwest Research Group - St. Charles Psychiatric Associates
    Saint Charles, Missouri
    Site status: Not listed — confirm with the team
  • Clinilabs
    New York, New York
    Site status: Not listed — confirm with the team
  • The Medical Research Network, LLC
    New York, New York
    Site status: Not listed — confirm with the team
  • Stony Brook University Medical Center
    Stony Brook, New York
    Site status: Not listed — confirm with the team
  • Ohio State University
    Columbus, Ohio
    Site status: Not listed — confirm with the team
  • Midwest Clinical Research Center
    Dayton, Ohio
    Site status: Not listed — confirm with the team
  • Paradigm Research Professionals, LLC
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Lehigh Center for Clinical Research
    Allentown, Pennsylvania
    Site status: Not listed — confirm with the team
  • University of Pennsylvania Medical Center
    Philadelphia, Pennsylvania
    Site status: Not listed — confirm with the team
  • The Warren Alpert Medical School of Brown University - Butler Hospital
    Providence, Rhode Island
    Site status: Not listed — confirm with the team
  • BioBehavioral Research of Austin PC
    Austin, Texas
    Site status: Not listed — confirm with the team
  • Relaro Medical Trials
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • University of Texas Southwestern Medical Center
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • Brain Health Consultants and TMS Center
    Houston, Texas
    Site status: Not listed — confirm with the team
  • The University of Texas Health Science Center at Houston
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Pillar Clinical Research, LLC
    Richardson, Texas
    Site status: Not listed — confirm with the team
  • Family Psychiatry of The Woodlands
    The Woodlands, Texas
    Site status: Not listed — confirm with the team
  • Grayline Research Center
    Wichita Falls, Texas
    Site status: Not listed — confirm with the team
  • University of Virginia Center for Psychiatric Clinical Research
    Charlottesville, Virginia
    Site status: Not listed — confirm with the team

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In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving Esketamine 56 mg, Esketamine 84 mg, Placebo. Phase 4 studies usually happen after treatment approval, to monitor real-world use.

Who might this study be for?

This study may concern people with depression; age range: Over 18 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Janssen Research & Development, LLC, which appears to be another type of organization. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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