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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: Completed Phase 3 study of Depressive Disorder, Treatment-Resistant, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to
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 |
What the finished NCT03434041 record still lists
NCT03434041 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, above the 210-participant average among 9 other Depressive Disorder, Treatment-Resistant trials with a reported enrollment target (20% higher).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Treatment-Resistant
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03434041's enrollment target sits among peer trials
252 2nd of 9 the highest of 9 other Depressive Disorder, Treatment-Resistant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Treatment-Resistant 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.
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