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NCT04623099: PrEcISE

Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)

Recruiting now Phase 4 Last updated 29 August 2024
What this trial tests

Phase 4 trial testing Escitalopram in Anxiety in 132 participants. Currently enrolling.

Timeline
8 March 2021
Primary endpoint
30 June 2026
1 December 2026

Quick facts

Lead sponsorUniversity of Cincinnati
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment132
Start date8 March 2021
Primary completion30 June 2026
Estimated completion1 December 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other trials of Escitalopram

Trials testing the same drug.

Other recruiting trials for Anxiety

Currently open trials in the same condition.

Other University of Cincinnati trials

Trials by the same sponsor.

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Data sources for this page

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