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RCT: Trazodone vs Quetiapine vs Placebo for Treating ICU Delirium (TraQ)

NCT05085808 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2026-05-04

No results posted yet for this study

Summary

The objective of this study is to evaluate the effectiveness of trazodone as compared to quetiapine and placebo, in the management of ICU delirium in adult (\>=18 years old) surgical ICU patients. The investigators will compare outcomes such as delirium incidence and duration, in-hospital mortality, 28-day mortality, hospital length of stay (LOS), ICU LOS, mechanical ventilator days, complications, adverse effects, rescue medication use, delirium symptom severity, sleep duration, and sleep quality among participants receiving trazodone, quetiapine, or placebo. The investigators hypothesize participants receiving trazodone will have a shorter duration of delirium, decreased delirium severity, and improved sleep quality compared to participants receiving quetiapine and placebo.

Conditions

  • Delirium
  • Morality
  • Quality of Life
  • Psych
  • Treatment Side Effects

Interventions

DRUG

Trazodone

Trazodone will be administered to ICU patients who need pharmacological intervention for delirium, if they are randomized to the trazodone arm.

DRUG

Quetiapine

Quetiapine will be administered to ICU patients who need pharmacological intervention for delirium, if they are randomized to the quetiapine arm.

DRUG

Placebo

Placebo will be administered to ICU patients who need pharmacological intervention for delirium, if they are randomized to the placebo arm.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Catherine M Kuza, MD, FASA · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-03-01
Primary Completion
2029-07-01
Completion
2030-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085808 on ClinicalTrials.gov