Tiny study compares trazodone and quetiapine for ICU delirium – but was cut short
NCT ID NCT05307003
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This pilot study aimed to compare trazodone and quetiapine for treating delirium in ICU patients. It enrolled only 10 adults in the surgical ICU who had delirium with symptoms like agitation or hallucinations. The study was terminated early, so the results are very limited and cannot provide clear answers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trazodone and quetiapine
- What this could lead to
- If successful, this could suggest a better option for managing ICU delirium with fewer side effects.
- What could go wrong
- This was a very small pilot study (only 10 participants) that was terminated early, so the findings are not reliable or generalizable.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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10 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Jun 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients admitted to the medical or surgical ICU for \>24 hours with delirium requiring treatment with either trazodone or quetiapine.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Keck Hospital of the University of Southern California
Los Angeles, California, 90033, United States
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