Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Tiny study compares trazodone and quetiapine for ICU delirium – but was cut short

NCT ID NCT05307003

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

10 people

The number who actually took part.

Started

Jun 2024

Finished

Jun 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Delirium are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Confusion delirium psychiatric disorder Sepsis-Associated Encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Keck Hospital of the University of Southern California

    Los Angeles, California, 90033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.