Trazodone vs Quetiapine for ICU Delirium (TraQ Trial)
Palo Alto (17 mi)Overseen byCatherine M Kuza, MD, FASA
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: University of Southern California
Prior Safety Data
Trial Summary
What is the purpose of this trial?The objective of this study is to evaluate the effectiveness of trazodone as compared to quetiapine and placebo, in the management of ICU delirium in adult (\>=18 years old) surgical ICU patients. The investigators will compare outcomes such as delirium incidence and duration, 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, quetiapine, or placebo. The investigators hypothesize participants receiving trazodone will have a shorter duration of delirium, decreased delirium severity, and improved sleep quality compared to participants receiving quetiapine and placebo.
Eligibility Criteria
Adults over 18 in the surgical ICU with delirium, needing medication as decided by their doctor. They must be able to give consent and not have conditions like severe heart issues, liver disease, certain mental health disorders, or be at risk of interactions with the study drugs.Inclusion Criteria
I have been in the surgical ICU for more than a day.
I am 18 years old or older.
Exclusion Criteria
I am currently experiencing severe withdrawal symptoms from alcohol or drugs that need treatment.
I have had a type of irregular heartbeat called ventricular arrhythmia.
I have been diagnosed with dementia.
I have been diagnosed with tardive dyskinesia.
I have a seizure disorder.
I need my medications crushed due to my feeding tube.
I have been diagnosed with Parkinson's disease or parkinsonism.
I have been diagnosed with liver disease.
I have a long QT interval on my EKG.
I have had a recent episode of irregular heart rhythm.
I am on medication that interacts with trazodone or quetiapine.
I do not have sudden brain dysfunction due to liver or kidney disease.
Treatment Details
The trial tests if trazodone is better than quetiapine or a placebo for treating ICU delirium. It looks at how long delirium lasts, mortality rates, hospital stay length, ventilator days needed, complications and sleep quality among patients.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: TrazodoneExperimental Treatment1 Intervention
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
Group II: QuetiapineActive Control1 Intervention
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
Group III: PlaceboPlacebo Group1 Intervention
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
Quetiapine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Seroquel for:
- Bipolar disorder (depressive and manic episodes)
- Schizophrenia
- Major depressive disorder
🇪🇺 Approved in European Union as Seroquel for:
- Schizophrenia
- Bipolar disorder (manic episodes)
- Major depressive episodes in bipolar disorder
Find a clinic near you
Research locations nearbySelect from list below to view details:
Keck Hospital of the University of Southern CaliforniaLos Angeles, CA
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor