Comparing trazodone and quetiapine for treating ICU delirium

Trazodone vs. Quetiapine for the Treatment of ICU Delirium: A Prospective Observational Pilot Study

This study is testing whether trazodone can help adults in the ICU with delirium feel better and sleep more soundly compared to quetiapine.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Southern California (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT05307003 on ClinicalTrials.gov

What this trial studies

This observational pilot study aims to evaluate the effectiveness of trazodone compared to quetiapine in managing ICU delirium among adult patients in a surgical and medical ICU. The study will assess various outcomes, including the duration of delirium, delirium-free days, and sleep quality, among others. Participants will be screened daily for eligibility, and those meeting the criteria will receive either trazodone or quetiapine as part of their treatment. The hypothesis is that trazodone will lead to better outcomes than quetiapine.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are admitted to the surgical ICU for more than 24 hours and diagnosed with ICU delirium.

Not a fit: Patients with acute neurological conditions, pregnancy, or a history of certain heart conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for ICU delirium, potentially improving patient outcomes and reducing healthcare costs.

How similar studies have performed: While there is limited literature on trazodone for ICU delirium, other studies have explored similar approaches with varying degrees of success.

Eligibility criteria

Inclusion Criteria:

* \>=18-years-old
* Admitted to the surgical ICU for \>24 hours
* 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
* Receiving either quetiapine or trazodone for the treatment of delirium

Exclusion Criteria:

* 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.
* Pregnancy/lactation
* History of ventricular arrhythmia including torsade de pointes or second- and third-degree heart block
* 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
* Patients in whom CAM-ICU cannot be performed to screen for delirium (i.e., acute encephalopathy, mental retardation, vegetative state, deaf, blind, etc.) \[reversible coma (that is, not caused by traumatic brain injury, cerebrovascular accident, or intracranial tumor), defined as RASS -4 or -5 at any point through one ICU day, is NOT an exclusion criterion.\]
* Inability to speak or understand English
* Expected to die or transfer out of the ICU within 24 hours
* Acute alcohol or substance abuse withdrawal symptoms/syndrome (i.e., delirium tremens) requiring treatment/intervention (e.g, implementation of the Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol, benzodiazepines, alpha-2 agonist, etc.)
* Prolonged QTc syndrome AND/OR prolonged QT-interval (QTc\>450 ms for men, and \>460 ms for women on ECG performed within 1 month of ICU admission or day of study enrollment)
* Active psychosis \[defined as distortion or loss of contact with reality, delusions and/or
* hallucinations (without insight), and/or thought disorder-must be diagnosed by a psychiatrist\]
* Patients taking medications with known interactions with either trazodone and/or quetiapine per Pharmacy (e.g., MAOIs (monoamine oxidase inhibitors), SSRIs (selective serotonin reuptake inhibitors; etc.)
* Acute encephalopathy (i.e., hepatic, uremic, etc.)
* Seizure disorder
* Myocardial infarction (MI) within the past 30 days
* Tardive dyskinesia
* Symptomatic hyponatremia
* Terminal state
* Diagnosis of liver disease
* Patients who are strict NPO (nil per os), are a high aspiration risk (defined as frequent nausea/vomiting, ileus, gastric dysmotility disorder, uncontrolled gastroesophageal reflux disease, 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 or solutions as determined by speech therapist
* Currently enrolled and participating in another interventional study
* Patients who have received both trazodone and quetiapine in the management of their delirium
* Patients who have had a history of serotonin syndrome
* Patients who were enrolled in the study once, are not eligible for re-enrollment if they are readmitted to the ICU

Where this trial is running

Los Angeles, California

• Keck Hospital of the University of Southern California — Los Angeles, California, United States (RECRUITING)

Study contacts

• Principal investigator: Catherine Kuza, MD, FASA — Keck School of Medicine of the University of Southern California
• Study coordinator: Catherine Kuza, MD, FASA

Conditions: Delirium, Delirium of Mixed Origin, Delirium, Sepsis Associated, Delirium in Old Age, Delirium Confusional State, Psych, Morality, Treatment Side Effects