Trazodone vs. Quetiapine for the Treatment of ICU Delirium

NCT05307003 | Terminated FDA Drug

• 1 other identifier: HS-22-00540
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective observational pilot study. The objective of this study is to evaluate the effectiveness of trazodone as compared to quetiapine, in the management of ICU delirium in adult (\>=18 years old) surgical and medical ICU patients. The investigators will compare outcomes such as delirium duration, delirium-free days, coma-free days, 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 or quetiapine. The investigators hypothesize participants receiving trazodone will be associated with a shorter duration of delirium, decreased delirium severity, and improved sleep quality compared to participants receiving quetiapine.

Conditions

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

Keywords

critical care; ICU delirium; trazodone; quetiapine; outcomes

Outcome Measures

Primary Outcomes (3)

• delirium duration using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) tool

  days

  14 days

• delirium-free days

  days

  14 days

• coma-free days

  days

  14 days

Secondary Outcomes (12)

• in-hospital mortality

  365 days

• ICU length of stay

  14 days

• total hospital length of stay

  14 days

• mechanical ventilator days

  14 days

• 28-day mortality

  28 days

Study Arms (2)

Quetiapine

Patients diagnosed with delirium who received quetiapine for treatment. * Start study medication at 25 mg daily PO ; may increase to BID (twice a day) or TID (three times a day) 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 (adverse effects) 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

Drug: Quetiapine

Trazodone

Patients diagnosed with delirium who received trazodone for treatment. * 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

Drug: Trazodone

Interventions

Trazodone DRUG

Medication used to treat ICU delirium

Also known as: Desyrel

Trazodone

Quetiapine DRUG

Medication used to treat ICU delirium

Also known as: Seroquel

Quetiapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the medical or surgical ICU for \>24 hours with delirium requiring treatment with either trazodone or quetiapine.

You may qualify if:

• \>=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

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Hospital of the University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (39)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Delirium; Sepsis-Associated Encephalopathy; Confusion

Interventions

Trazodone; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Catherine Kuza, MD, FASA

  Keck School of Medicine of the University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: June 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)