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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post-randomization (measured at 1-, 3-, 6-months post-randomization)
Awards & highlights
TraQ 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.Check my eligibility
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.See study design
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.
TraQ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been in the surgical ICU for more than a day.
Select...
I am 18 years old or older.
TraQ Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Delirium duration using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) tool
Secondary outcome measures
28-day mortality
Delirium severity
ICU length of stay
+13 moreTraQ 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
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trazodone
2011
Completed Phase 4
~2380
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,258 Total Patients Enrolled
2 Trials studying Delirium
164 Patients Enrolled for Delirium
Catherine M Kuza, MD, FASAPrincipal InvestigatorUniversity of Southern California
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have had a serious reaction to certain medications that affect the brain.You are allergic or have a strong reaction to trazodone or quetiapine.I have not had a heart attack in the last 30 days.I have been diagnosed with dementia.I have been diagnosed with tardive dyskinesia.I was admitted to the ICU with a recent severe brain condition.I have a seizure disorder.I need my medications crushed due to my feeding tube.I have ICU delirium needing medication, confirmed by a CAM-ICU score.I have been diagnosed with Parkinson's disease or parkinsonism.You have a very advanced and serious medical condition.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.You are currently experiencing severe mental health issues that affect your thoughts and behavior.You are not expected to leave the intensive care unit (ICU) within the next 24 hours.I am on medication that interacts with trazodone or quetiapine.I have been in the surgical ICU for more than a day.Low sodium levels in the bloodI am 18 years old or older.You are unable to participate in a test for delirium due to certain medical conditions or disabilities like severe confusion, cognitive impairment, or being deaf or blind.I do not have sudden brain dysfunction due to liver or kidney disease.You have trouble swallowing, have a high risk of food going into your lungs, or have trouble eating or drinking by mouth.
Research Study Groups:
This trial has the following groups:- Group 1: Trazodone
- Group 2: Placebo
- Group 3: Quetiapine
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any volunteers being enrolled in this trial at present?
"Unfortunately, this study has met its recruitment goals and is no longer accepting patients. It was first posted on March 1st 2023 but was last updated on 30th of March 2022. For those searching for other clinical trials, there are currently 412 active studies recruiting participants with mortality concerns and 18 involving the use of trazodone."
Answered by AI
Has this experiment been undertaken before?
"Since 2014, Otsuka America Pharmaceutical has conducted 18 distinct drug trials for Trazodone in 157 cities and 27 nations. Moreover, since its inception these studies have involved a total of 18489 individuals. Notably the first experiment was completed at Phase 4 FDA approval stage in that same year with 200 participants."
Answered by AI
How many participants have enrolled in this experiment thus far?
"This clinical research has ceased recruitment of participants. Initially listed on March 1st 2023 and last revised on 30th March 2022, the trial is no longer recruiting patients. For those seeking other studies to join, there are 412 trials searching for enrollees regarding mortality as well as 18 studies enrolling people for Trazodone treatment."
Answered by AI
In what kind of medical scenarios is the administration of Trazodone beneficial?
"Trazodone is traditionally employed to tackle mental depression, but its efficacy has also been demonstrated in treating dementia, post traumatic stress disorder (PTSD), and eating disorders."
Answered by AI
What are the attendant risks associated with Trazodone consumption?
"The safety rating of Trazodone is a 3, which reflects the fact that it has achieved Phase 4 testing and been approved by regulatory bodies."
Answered by AI
Are there any previous experiments which have studied Trazodone's efficacy?
"At the current time, 18 clinical trials involving trazodone are actively being conducted. Of these studies, 5 are in their third phase of testing. While most tests take place in Bhubaneswar, Orissa, 473 distinct locations around the world have opened for volunteers to participate and contribute data."
Answered by AI
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