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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03434041
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 252 participants
Conditions and interventions
Conditions
Interventions
- Esketamine 56 mg Drug
- Esketamine 84 mg Drug
- Placebo Drug
- Duloxetine (Oral Antidepressant) Drug
- Escitalopram (Oral Antidepressant) 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.
Recently updated Depressive Disorder, Treatment-Resistant trials
Other public records listing Depressive Disorder, Treatment-Resistant. Sorted by last update posted; newest first. Not a recommendation.
- NCT07758010: One-Day cTBS Over the Precuneus Not yet recruiting
- NCT07716098: A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression Recruiting
- NCT07284667: ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response Recruiting
- NCT02994433: NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits Recruiting
- NCT03851380: Improving Brain Stimulation Through Imaging Active, not recruiting
- NCT06511908: Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression Recruiting
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 Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03434041 live on ClinicalTrials.gov.