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Antipsychotic

Trazodone vs Quetiapine for ICU Delirium (TraQ Trial)

Phase 4

Waitlist Available

Led By Catherine M Kuza, MD, FASA

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted to the surgical ICU for >24 hours

>=18-years-old

Must not have

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.)

History of ventricular arrhythmia including torsade de pointes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post-randomization (measured at 1-, 3-, 6-months post-randomization)

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is looking at whether trazodone is better than quetiapine or a placebo at managing ICU delirium in adult surgical ICU patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include dizziness, dry mouth, fatigue for both trazodone and quetiapine; plus specific risks like heart rhythm problems for quetiapine. Side effects can vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been in the surgical ICU for more than a day.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing severe withdrawal symptoms from alcohol or drugs that need treatment.

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I have had a type of irregular heartbeat called ventricular arrhythmia.

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I have been diagnosed with dementia.

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I have been diagnosed with tardive dyskinesia.

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I have a seizure disorder.

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I need my medications crushed due to my feeding tube.

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I have been diagnosed with Parkinson's disease or parkinsonism.

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I have been diagnosed with liver disease.

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I have a long QT interval on my EKG.

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I have had a recent episode of irregular heart rhythm.

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I am on medication that interacts with trazodone or quetiapine.

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I do not have sudden brain dysfunction due to liver or kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post-randomization (measured at 1-, 3-, 6-months post-randomization)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post-randomization (measured at 1-, 3-, 6-months post-randomization)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post-randomization (measured at 1-, 3-, 6-months post-randomization) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

28-day mortality

Delirium severity

ICU length of stay

+13 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trazodone

2011

Completed Phase 4

~2540

0 / 14Eligibility criteria met