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A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
NCT03434041 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal esketamine (56 milligram \[mg\] or 84 mg) plus a newly initiated oral antidepressant compared with switching to a newly initiated oral antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms. Efficacy will be assessed by the change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score from Day 1 (before randomization) to the end of the 4-week double-blind treatment phase.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Esketamine 56 mg
- DRUG Esketamine 84 mg
- DRUG Duloxetine (Oral Antidepressant)
- DRUG Escitalopram (Oral Antidepressant)
Study Locations (20)
Other
- Beijing Anding Hospital of Capital Medical University — Beijing
- Beijing HuiLong Guan Hospital — Beijing
- Peking University Sixth Hospital — Beijing
- The Second People's Hospital of Hunan Province / Brian Hospital of Hunan Province — Changsha
- The second Xiangya Hospital of Central South University — Changsha
- West China Hospital Sichuan University — Chengdu
- Chongqing Mental Health Center — Chongqing
- the 3rd Affiliated Hospital,Sun Yansen University — Guangzhou
- Guangdong Provincial People's Hospital — Guangzhou
- Hangzhou Seventh People's Hospital — Hangzhou
- First Hospital, Zhejiang University Medical College — Hangzhou
- The Second Affiliated Hospital of Zhejiang University — Hangzhou
- Huzhou third people's Hospital — Huzhou
- First Affiliated Hospital of Kunming Medical Unversity — Kunming
Georgia
- Atlanta Center for Medical Research — Atlanta
Louisiana
- Biomedical Research Foundation of Northwest Louisiana — Shreveport
Maryland
- CBH Health — Gaithersburg
Massachusetts
- Adams Clinical — Watertown
New York
- The Medical Research Network, LLC — New York
Oklahoma
- IPS Research Company — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2018-05-25 |
| Est. Completion | 2021-04-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03434041
The ClinicalTrials.gov registry entry for NCT03434041 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Depressive Disorder, Treatment-Resistant appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03434041 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Georgia, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03434041 about?
NCT03434041 is a clinical study titled "A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression". The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal esketamine (56 milligram \[mg\] or 84 mg) plus a newly initiated oral ...
What is the current status of trial NCT03434041?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 252 participants. The study started on 2018-05-25. Estimated completion is 2021-04-13.
What conditions does trial NCT03434041 study?
This clinical trial studies the following conditions: Depressive Disorder, Treatment-Resistant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03434041?
The interventions under investigation include: Placebo (DRUG), Esketamine 56 mg (DRUG), Esketamine 84 mg (DRUG), Duloxetine (Oral Antidepressant) (DRUG), Escitalopram (Oral Antidepressant) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03434041?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03434041 being conducted?
This trial has 20 study locations across Georgia, Louisiana, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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