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NCT02343575 · ClinicalTrials.gov registry record · Phase 4
Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU
A Phase 4 study, sponsored by Stanford University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT02343575: Clinical Trial Phase 4 study, sponsored by Stanford University.
NCT02343575 is a Phase 4 study that was terminated before completion, run by Stanford University. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02343575, a Phase 4 study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
Delirium is the most often encountered psychiatric diagnosis in the general hospital, with incidence up to 85% in the intensive care unit (ICU) setting and with significant consequences on patients' morbidity and mortality. Currently, although not FDA approved, antipsychotics are often considered the first-line pharmacological treatment. However, there can be limitations to their use, including side effects or lack of efficacy. Valproic acid (VPA) is one of the alternatives at times used in such patients which from limited case series data appears to be helpful and tolerated. VPA can provide relief from agitation that poses a threat to the safety and recovery of the patient. Moreover, mechanistically it addresses the neurochemical and cellular abnormalities inherent in delirium (it has NMDA-antagonist, anti-dopaminergic, GABAergic,anti-inflammatory, anti-apoptotic, and histone deacetylase inhibitor properties, among others). The purpose of this study is to evaluate the efficacy and tolerability of the VPA in the first known to us randomized controlled trial.
Primary Outcome
Delirium resolution was defined as three negative Confusion Assessment Method (CAM) assessments, performed by nurses every 12 hours.
Interventions
- DRUG Placebo
- DRUG Haloperidol
- DRUG Valproic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-01 |
| Est. Completion | 2018-01 |
| Phase | Phase 4 |
Why NCT02343575 stopped before completion
NCT02343575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02343575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02343575 about?
NCT02343575 is a clinical study titled "Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU". Delirium is the most often encountered psychiatric diagnosis in the general hospital, with incidence up to 85% in the intensive care unit (ICU) setting and with significant consequences on patients' morbidity and mortality. Currently, although not FDA approved, antipsychotics are often considered th...
What is the current status of trial NCT02343575?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2015-01. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02343575?
The interventions under investigation include: Placebo (DRUG), Haloperidol (DRUG), Valproic Acid (DRUG).
Who is sponsoring clinical trial NCT02343575?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02343575's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 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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