Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02497287 · ClinicalTrials.gov registry record · Phase 3
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 802
- Enrollment target
NCT02497287: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02497287 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 802 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02497287, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 802 participants
- Enrollment target
Study Summary
The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).
Primary Outcome
An adverse event is any untoward medical occurrence in a clinical study participants who administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the treatment. A TEAE defined as an event that was new in onset or increased in severity following treatment initiation.
Interventions
- DRUG Duloxetine (Oral Antidepressant)
- DRUG Escitalopram (Oral Antidepressant)
- DRUG Sertraline (Oral Antidepressant)
- DRUG Esketamine (Intranasal Spray)
- DRUG Venlafaxine Extended Release (XR) (Oral Antidepressant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2015-09-30 |
| Est. Completion | 2017-10-28 |
| Phase | Phase 3 |
What the finished NCT02497287 record still lists
NCT02497287 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Duloxetine (Oral Antidepressant) is the first listed.
NCT02497287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02497287 about?
NCT02497287 is a clinical study titled "A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression". The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).
What is the current status of trial NCT02497287?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 802 participants. The study started on 2015-09-30. Estimated completion is 2017-10-28.
What interventions are being tested in trial NCT02497287?
The interventions under investigation include: Duloxetine (Oral Antidepressant) (DRUG), Escitalopram (Oral Antidepressant) (DRUG), Sertraline (Oral Antidepressant) (DRUG), Esketamine (Intranasal Spray) (DRUG), Venlafaxine Extended Release (XR) (Oral Antidepressant) (DRUG).
Who is sponsoring clinical trial NCT02497287?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02497287's enrollment target sits among peer trials
802 413th of 2000 higher than 1,587 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03524430 · 801 participants · NA
RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
- NCT04423211 · 804 participants · Phase 3
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
- NCT06522022 · 804 participants · NA
PTSD Screening in Pregnant Black Women
- NCT00695214 · 800 participants · Phase 2
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI