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
Public ClinicalTrials.gov record NCT03434041. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT03434041
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Janssen Research & Development, LLC
- Industry
- Enrollment
- 252 participants
Conditions and interventions
Conditions
Interventions
- Duloxetine (Oral Antidepressant) Drug
- Escitalopram (Oral Antidepressant) Drug
- Esketamine 56 mg Drug
- Esketamine 84 mg Drug
- Placebo Drug
- Sertraline (Oral Antidepressant) Drug
- Venlafaxine Extended Release (XR) (Oral Antidepressant) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 24, 2018
- Primary completion
- Apr 12, 2021
- Completion
- Apr 12, 2021
- Last update posted
- Apr 28, 2025
2018 – 2021
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Biomedical Research Foundation of Northwest Louisiana | Shreveport | Louisiana | 71104-2136 | — |
| CBH Health | Gaithersburg | Maryland | 20877 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| The Medical Research Network, LLC | New York | New York | 10128 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03434041, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2025 · Synced May 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03434041 live on ClinicalTrials.gov.