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New treatment option for Mild Traumatic Brain Injury
Official title Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)
ClinicalTrials.gov ID: NCT06333990
What this study is testing
What is Quetiapine Fumarate?
Quetiapine Fumarate is an investigational medicine, being studied as a potential treatment for mild traumatic brain injury.
Also referred to as Seroquel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female veterans seeking treatment for mTBI, aged 18-65 years
- Meet mTBI diagnosis and have PCS symptoms reported on the Neurobehavioral Symptom Inventory (NSI). Six months or more must elapse between the injury...
- Be stable (i.e., no dose changes for \> 1 month) on at least three CNS active psychotropic medications prescribed for symptom relief or psychiatric...
- Have posttraumatic symptoms measured by PTSD Checklist for DSM-5 (PCL-5) score ≥25.
You likely can't join if
- Moderate or severe TBI, or major neurocognitive disorder (dementia).
- Meet DSM-5 criteria for schizophrenia, bipolar disorder, schizoaffective disorder, or requiring inpatient hospitalization currently or within past 6...
- Currently taking any antipsychotics or prohibited medication within the past month .
- Known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal, hematological, or endocrinological condition, diabetes...
- Substance use disorder severe enough to require medication treatment or medical detoxification or inpatient hospitalization within 6 months of...
- Reporting suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months prior to screening or at...
See the full eligibility criteria
- Male or female veterans seeking treatment for mTBI, aged 18-65 years
- Meet mTBI diagnosis and have PCS symptoms reported on the Neurobehavioral Symptom Inventory (NSI). Six months or more must elapse between the injury and Screening. mTBI diagnosis will be determined using the provisional...
- Be stable (i.e., no dose changes for \> 1 month) on at least three CNS active psychotropic medications prescribed for symptom relief or psychiatric treatment.
- Have posttraumatic symptoms measured by PTSD Checklist for DSM-5 (PCL-5) score ≥25.
- Moderate or severe TBI, or major neurocognitive disorder (dementia).
- Meet DSM-5 criteria for schizophrenia, bipolar disorder, schizoaffective disorder, or requiring inpatient hospitalization currently or within past 6 months.
- Currently taking any antipsychotics or prohibited medication within the past month .
- Known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal, hematological, or endocrinological condition, diabetes mellitus, severe sleep apnea and/or seizure disorder.
- Substance use disorder severe enough to require medication treatment or medical detoxification or inpatient hospitalization within 6 months of screening.
- Reporting suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months prior to screening or at screening or baseline visit (i.e. active suicidal thought with method and...
- Current or known history of cardiac arrhythmia or QTc interval ≥ 470 milliseconds.
- Pregnant or lactating women and those of child-bearing potential not using a reliable method of contraception will be excluded from participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Albuquerque, New Mexico, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albuquerque, New Mexico, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.