ICU delirium drug study pulled before starting
NCT ID NCT05085808
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if trazodone works better than quetiapine or a placebo for treating confusion (delirium) in adult surgical ICU patients. It planned to measure how long delirium lasts, sleep quality, and side effects. However, the study was withdrawn before enrolling any participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Expected to start
-
Mar 2028
An estimate. Start dates often move.
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- 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.
- Ages
-
18 years and older
- Sex
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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 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: 1. \>=18-years-old 2. Admitted to the surgical ICU for \>24 hours 3. Written informed consent obtained from the patient or their surrogate decision maker. 4. 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 Exclusion Criteria: 1. 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.) 2. Recent torsade de pointes or ventricular arrhythmia 3. Prolonged QTc syndrome AND/OR prolonged QT-interval (QTc\>500 ms on baseline EKG, performed on the day of randomization) 4. Active psychosis 5. Patients taking medications with known interactions with either trazodone and/or quetiapine 6. Acute encephalopathy (i.e., hepatic, uremic, etc.) 7. Seizure disorder 8. myocardial infarction (MI) within the past 30 days 9. Tardive dyskinesia 10. Hyponatremia 11. Terminal state 12. Diagnosis of liver disease 13. 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 14. 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) 15. 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. 16. Pregnancy/lactation 17. History of ventricular arrhythmia including torsade de pointes 18. Allergy/hypersensitivity reaction to trazodone and/or quetiapine 19. Diagnosis of dementia 20. History of neuroleptic malignant syndrome and/or serotonin syndrome 21. Diagnosis of Parkinson's disease or parkinsonism (also referred to as hypokinetic rigidity syndrome) 22. Schizophrenia or other psychotic disorder 23. Patients in whom CAM-ICU cannot be performed to screen for delirium (i.e., acute encephalopathy, mental retardation, vegetative state/coma, deaf, blind, etc.) 24. Inability to speak or understand English 25. Expected to die or transfer out of the ICU within 24 hours 26. Currently enrolled and participating in another interventional study 27. No signed written informed consent by patient or their surrogate decision maker.
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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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