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NCT03993457 · ClinicalTrials.gov registry record · Phase 4
Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT03993457: Clinical Trial Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT03993457 is a Phase 4 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03993457, a Phase 4 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study Summary
PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants to evaluate if the level of inflammation in our body can predict how we will respond to antidepressants. C-reactive protein (CRP) is a substance in the body that is associated with inflammation. Previous research has suggested that people with high CRP (i.e., high inflammation levels) tend to have greater improvement of depressive symptoms with an antidepressant called bupropion, while individuals with low CRP (i.e., low inflammation levels) appear to have more benefit from selective serotonin reuptake inhibitors antidepressants (SSRI), such as escitalopram. However, it is not completely clear if CRP can predict your response to these two antidepressants. Participants will undergo a screening visit that includes a physical exam, overall health evaluation, assessment of mental health history, and a toxicology and pregnancy test. Once screening is complete, participants will be randomized to one of two groups that will determine whether their CRP levels will be used to select which antidepressant they will receive. Participants will then complete 4 follow up visits at weeks 2, 4, 6, and 8. A follow-up phone call from the study team will occur at week 12.
Primary Outcome
The primary study endpoint will be remission rates based on the 16-items Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR), which will be extracted from the 30-item Inventory of Depressive Symptomatology (IDS-SR). The QIDS-SR score ranges from 0-27. A score of 5 or less represents remission.
Interventions
- DRUG Escitalopram
- DRUG Bupropion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2022-03-25 |
| Phase | Phase 4 |
Why NCT03993457 stopped before completion
NCT03993457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Escitalopram is the first listed.
NCT03993457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03993457 about?
NCT03993457 is a clinical study titled "Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression". PRECISE-D is a single site, randomized, open label 8-week clinical trial that will enroll 70 participants to evaluate if the level of inflammation in our body can predict how we will respond to antidepressants. C-reactive protein (CRP) is a substance in the body that is associated with inflammation....
What is the current status of trial NCT03993457?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2019-07-23. Estimated completion is 2022-03-25.
What interventions are being tested in trial NCT03993457?
The interventions under investigation include: Escitalopram (DRUG), Bupropion (DRUG).
Who is sponsoring clinical trial NCT03993457?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03993457's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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