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NCT04623099: PrEcISE
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
Phase 4 trial testing Escitalopram in Anxiety in 132 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | University of Cincinnati |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 8 March 2021 |
| Primary completion | 30 June 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Escitalopram (escitalopram) — full drug profile →
Conditions studied
- Anxiety — all drugs for Anxiety →
Sponsor
University of Cincinnati
Who can join
Adults 12 to 17, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The emergence, implementation, and future growth of pharmacogenomics in psychiatry: a narrative review.
Bousman CA, Maruf AA, Marques DF, Brown LC, et al · · 2023 · cited 37× · PMID 37772416 · DOI 10.1017/s0033291723002817 -
Pharmacogenetically Guided Escitalopram Treatment for Pediatric Anxiety Disorders: Protocol for a Double-Blind Randomized Trial.
Strawn JR, Poweleit EA, Mills JA, Schroeder HK, et al · · 2021 · cited 9× · PMID 34834540 · DOI 10.3390/jpm11111188 -
A Double-Blind Randomized Trial to Investigate Mechanisms of Antidepressant-Related Dysfunctional Arousal in Depressed or Anxious Youth at Familial Risk for Bipolar Disorder.
Honeycutt DC, DelBello MP, Strawn JR, Ramsey LB, et al · · 2022 · cited 4× · PMID 35743790 · DOI 10.3390/jpm12061006
Verify or expand the search:
- PubMed search for NCT04623099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04623099 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cincinnati
- Last refreshed: 29 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04623099.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing