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NCT04623099 · ClinicalTrials.gov registry record · Phase 4
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
A Phase 4 study of Anxiety, sponsored by University of Cincinnati.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT04623099: Recruiting Phase 4 study of Anxiety, sponsored by University of Cincinnati.
NCT04623099 is a Phase 4 study of Anxiety that is actively recruiting participants, run by University of Cincinnati. The registered enrollment target is 132 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04623099, a Phase 4 study of Anxiety, is actively recruiting participants, sponsored by University of Cincinnati.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.
Primary Outcome
Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score. The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders in children and adolescents. The PARS score is derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7)
Conditions Studied
Interventions
- DRUG Escitalopram
Study Locations (1)
Ohio
- University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 4 |
What NCT04623099 shows while recruiting
NCT04623099 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Anxiety appearing as the primary indexed condition, and to 1 intervention - of which Escitalopram is the first listed.
NCT04623099 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04623099 about?
NCT04623099 is a clinical study titled "Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)". This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.
What is the current status of trial NCT04623099?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 132 participants. The study started on 2021-03-08. Estimated completion is 2026-12-01.
What conditions does trial NCT04623099 study?
This clinical trial studies the following conditions: Anxiety.
What interventions are being tested in trial NCT04623099?
The interventions under investigation include: Escitalopram (DRUG).
Who is sponsoring clinical trial NCT04623099?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04623099 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety
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 NCT04623099's enrollment target sits among peer trials
132 135th of 364 higher than 230 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety 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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