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CompletedNCT03434041

Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant for treatment-resistant depression

This study is completed in the United States and in China. It is testing flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant for treatment-resistant depression.

DepressionDrugFrom 18 Years to 64 Years

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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In plain English

Key information made simple

What is this study testing?

This study is testing whether Esketamine 56 mg may be useful for adults experiencing depression.

What would participation involve?

Participants may receive Esketamine 56 mg, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in China and in the United States.

Who is it mainly for?

This study appears to be mainly for adults with depression.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • 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?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: May 25, 2018
Recruitment status
Completed
Enrollment listed in the registry
252
Sponsor
Janssen Research & Development, LLC
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, China
Age range
From 18 Years to 64 Years
Official registry ID
NCT03434041
Official title
A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects 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.

View official study record (opens in a new tab)

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

China · 24 sites
  • Beijing Anding Hospital of Capital Medical University
    Beijing
    Site status: Not listed — confirm with the team
  • Beijing HuiLong Guan Hospital
    Beijing
    Site status: Not listed — confirm with the team
  • Peking University Sixth Hospital
    Beijing
    Site status: Not listed — confirm with the team
  • The Second People's Hospital of Hunan Province / Brian Hospital of Hunan Province
    Changsha
    Site status: Not listed — confirm with the team
  • The second Xiangya Hospital of Central South University
    Changsha
    Site status: Not listed — confirm with the team
  • West China Hospital Sichuan University
    Chengdu
    Site status: Not listed — confirm with the team
  • Chongqing Mental Health Center
    Chongqing
    Site status: Not listed — confirm with the team
  • the 3rd Affiliated Hospital,Sun Yansen University
    Guangzhou
    Site status: Not listed — confirm with the team
  • Guangdong Provincial People's Hospital
    Guangzhou
    Site status: Not listed — confirm with the team
  • Hangzhou Seventh People's Hospital
    Hangzhou
    Site status: Not listed — confirm with the team
  • First Hospital, Zhejiang University Medical College
    Hangzhou
    Site status: Not listed — confirm with the team
  • The Second Affiliated Hospital of Zhejiang University
    Hangzhou
    Site status: Not listed — confirm with the team
  • Huzhou third people's Hospital
    Huzhou
    Site status: Not listed — confirm with the team
  • First Affiliated Hospital of Kunming Medical Unversity
    Kunming
    Site status: Not listed — confirm with the team
  • Nanjing Brain Hospital Affilicated to Nanjing Medical University
    Nanjing
    Site status: Not listed — confirm with the team
  • The First Hospital of Hebei Medical University
    Shijiazhuang
    Site status: Not listed — confirm with the team
  • Tianjin Anding Hospital
    Tianjin
    Site status: Not listed — confirm with the team
  • Urumqi fourth Hospital
    Ürümqi
    Site status: Not listed — confirm with the team
  • The first affiliated hospital of Xinjiang medical university
    Ürümqi
    Site status: Not listed — confirm with the team
  • Renmin Hospital of Wuhan University
    Wuhan
    Site status: Not listed — confirm with the team
  • The First Affiliated Hospital of Xian Jiaotong University
    Xi'an
    Site status: Not listed — confirm with the team
  • Xi'an Mental Health Center
    Xi'an
    Site status: Not listed — confirm with the team
  • Xiamen Xianyue Hospital
    Xiamen
    Site status: Not listed — confirm with the team
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou
    Site status: Not listed — confirm with the team
United States · 6 sites
  • Atlanta Center for Medical Research
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Biomedical Research Foundation of Northwest Louisiana
    Shreveport, Louisiana
    Site status: Not listed — confirm with the team
  • CBH Health
    Gaithersburg, Maryland
    Site status: Not listed — confirm with the team
  • Adams Clinical
    Watertown, Massachusetts
    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
  • IPS Research Company
    Oklahoma City, Oklahoma
    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, Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant), Sertraline (Oral Antidepressant), Venlafaxine Extended Release (XR) (Oral Antidepressant). Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with depression; age range: From 18 Years to 64 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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