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NCT03434041 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Depressive Disorder, Treatment-Resistant, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
252
Enrollment target
20
Study locations

NCT03434041 is a Phase 3 study of Depressive Disorder, Treatment-Resistant that has completed, run by Janssen Research & Development. The registered enrollment target is 252 participants, above the 210-participant average among 9 other Depressive Disorder, Treatment-Resistant trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT03434041, a Phase 3 study of Depressive Disorder, Treatment-Resistant, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
252 participants
Enrollment target
20
Study locations

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

Depressive Disorder, Treatment-Resistant

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

FieldValue
Enrollment Target 252 participants
Start Date 2018-05-25
Est. Completion 2021-04-13
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

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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, categorized as Phase 3. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 210-participant average among 9 other Depressive Disorder, Treatment-Resistant trials with a reported enrollment target (20% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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.

NCT03434041 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Georgia, Louisiana.

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.

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).

Who is sponsoring clinical trial NCT03434041?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.