RCT: Trazodone vs Quetiapine vs Placebo for Treating ICU Delirium (TraQ)
Key facts
- Who runs it
- University of Southern California
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 4
- Starts
- 1 Mar 2028
- Expected to end
- 1 Dec 2030
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Trazodone
- Quetiapine
- Placebo
- Record updated
- 4 May 2026
- Why it stopped
- PI left institution. Study never started.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 31 criteriaShow less
Who can take part
- >=18-years-old
- Admitted to the surgical ICU for >24 hours
- Written informed consent obtained from the patient or their surrogate decision maker
- Diagnosis of ICU delirium defined by positive CAM-ICU score AND exhibiting symptomatic delirium (i.e., combative, pulling at lines, a danger to self or others, inability to sleep, hallucinations, etc.), thus, requiring the need for pharmacologic intervention as determined by the attending intensivist
Who cannot take part
- Patients taking medications with known interactions with either trazodone and/or quetiapine
- Patients who have enteral access such as a small-bore feeding tube, nasogastric or orogastric tube, or gastrostomy/gastrojejunostomy tube (as these patients will need medications crushed in order to administer via the tube, and the capsules used in this study cannot be crushed)
- Acute alcohol or substance abuse withdrawal symptoms/syndrome (i.e., delirium tremens) requiring treatment/intervention (i.e., implementation of the Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol, benzodiazepines, alpha-2 agonist, etc.)
- Recent torsade de pointes or ventricular arrhythmia
- Seizure disorder
- myocardial infarction (MI) within the past 30 days
- Diagnosis of liver disease
- Patients who are strict NPO, are a high aspiration risk (defined as frequent nausea/vomiting, ileus, gastric dysmotility disorder, uncontrolled GERD, weakness/deconditioning, diabetes with gastroparesis, not tolerating full tube feeds if being enterally fed (high residual gastric volume >500 cc), elderly patients with waxing/waning mental status), have dysphagia, and/or have difficulty swallowing capsules as determined by speech therapist
- Presence of an acute neurologic condition (i.e., acute cerebrovascular accident, intracranial tumor, traumatic brain injury, etc.) on ICU admission. History of stroke or other neurological condition(s) without cognitive impairment is not an exclusion criterion
- History of ventricular arrhythmia including torsade de pointes
- Allergy/hypersensitivity reaction to trazodone and/or quetiapine
- Diagnosis of dementia
- History of neuroleptic malignant syndrome and/or serotonin syndrome
- Diagnosis of Parkinson's disease or parkinsonism (also referred to as hypokinetic rigidity syndrome)
- Schizophrenia or other psychotic disorder
- Prolonged QTc syndrome AND/OR prolonged QT-interval (QTc>500 ms on baseline EKG, performed on the day of randomization)
- Active psychosis
- Acute encephalopathy (i.e., hepatic, uremic, etc.)
- Tardive dyskinesia
- Hyponatremia
- Terminal state
- Pregnancy/lactation
- Patients in whom CAM-ICU cannot be performed to screen for delirium (i.e., acute encephalopathy, mental retardation, vegetative state/coma, deaf, blind, etc.)
- Inability to speak or understand English
- Expected to die or transfer out of the ICU within 24 hours
- Currently enrolled and participating in another interventional study
- No signed written informed consent by patient or their surrogate decision maker
Where in United States
- Keck Hospital of the University of Southern CaliforniaLos Angeles, United States
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- QuetiapineExisting treatment, for comparison
Start study medication at 25 mg daily PO ; may increase to BID or TID if RASS\>=2 or rescue medication must be given; thereafter, if med is TID, dose can be increased by increment of 50 mg q12 hr if RASS\>=2 and/or \>1 dose of rescue medication is given within 24 hours \[max dose 200 mg/day\] * dose can be reduced/discontinued per discretion of ICU attending if delirium improving, patient experiences AE likely related to study drug, after 14 days of treatment, or patient is discharged from ICU * dose should be held if RASS is -3 to -5/comatose/unresponsive or sudden acute change in mental status
- TrazodoneTreatment being tested
Start study medication at 25 mg daily PO ; may increase to BID or TID if RASS\>=2 or rescue medication must be given; thereafter, if med is TID, dose can be increased by increment of 50 mg q12 hr if RASS\>=2 and/or \>1 dose of rescue medication is given within 24 hours \[max dose 200 mg/day\] * dose can be reduced/discontinued per discretion of ICU attending if delirium improving, patient experiences AE likely related to study drug, after 14 days of treatment, or patient is discharged from ICU * dose should be held if RASS is -3 to -5/comatose/unresponsive or sudden acute change in mental status
- PlaceboPlacebo, for comparison
Start study medication at 25 mg daily PO ; may increase to BID or TID if RASS\>=2 or rescue medication must be given; thereafter, if med is TID, dose can be increased by increment of 50 mg q12 hr if RASS\>=2 and/or \>1 dose of rescue medication is given within 24 hours \[max dose 200 mg/day\] * dose can be reduced/discontinued per discretion of ICU attending if delirium improving, patient experiences AE likely related to study drug, after 14 days of treatment, or patient is discharged from ICU * dose should be held if RASS is -3 to -5/comatose/unresponsive or sudden acute change in mental status
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of Trazodone vs Quetiapine vs Placebo for the Treatment of ICU Delirium: A Randomized Controlled Trial (The TraQ Study)
- Record updated
- 4 May 2026