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NCT04565145 · ClinicalTrials.gov registry record · Phase 2
Biomarker Changes and Anxiolytic Effects-Phase 2
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT04565145: Completed Phase 2 study, sponsored by University of Florida.
NCT04565145 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04565145, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder.
Primary Outcome
The change in mean PRKACA value from pre to post-treatment
Interventions
- DRUG Placebo
- DRUG Kava Dietary Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-04-05 |
| Est. Completion | 2023-07-01 |
| Phase | Phase 2 |
What the finished NCT04565145 record still lists
NCT04565145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04565145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04565145 about?
NCT04565145 is a clinical study titled "Biomarker Changes and Anxiolytic Effects-Phase 2". This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiet...
What is the current status of trial NCT04565145?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2021-04-05. Estimated completion is 2023-07-01.
What interventions are being tested in trial NCT04565145?
The interventions under investigation include: Placebo (DRUG), Kava Dietary Supplement (DRUG).
Who is sponsoring clinical trial NCT04565145?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04565145's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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