Clinical trial NCT06333990: Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)
Official title: A Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Mild Traumatic Brain Injury
Keywords: Post Concussive Syndrome (PCS)
Posttraumatic Stress Disorder (PTSD)
Polypharmacy
Quetiapine
Veterans
Lead sponsor: Foundation for Advancing Veterans' Health Research
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: Biomedical Research Institute of New Mexico
First posted: 2024-03-27
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Male or female veterans seeking treatment for mTBI, aged 18-65 years
2. 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 diagnostic convention recommended by the VA/DoD requiring loss of consciousness, or a period of altered consciousness, or posttraumatic amnesia;
3. 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.
4. Have posttraumatic symptoms measured by PTSD Checklist for DSM-5 (PCL-5) score ≥25.

Exclusion Criteria:

1. Moderate or severe TBI, or major neurocognitive disorder (dementia).
2. Meet DSM-5 criteria for schizophrenia, bipolar disorder, schizoaffective disorder, or requiring inpatient hospitalization currently or within past 6 months.
3. Currently taking any antipsychotics or prohibited medication within the past month .
4. 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.
5. Substance use disorder severe enough to require medication treatment or medical detoxification or inpatient hospitalization within 6 months of screening.
6. 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 intent but without specific plan, or active suicidal thought with method, intent, and plan); or homicidal ideation with intent or plan to harm others within 90 days or suicide attempt; or suicidal behavior within 6 months prior to screening.

   (Note: Study psychiatrist will be immediately notified when SI or HI intent is positive)
7. Current or known history of cardiac arrhythmia or QTc interval ≥ 470 milliseconds.
8. 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.

Primary outcomes:
measure: Neurobehavioral Symptom Inventory
timeFrame: 2 weeks
measure: World Health Organization Disability Assessment Scale
timeFrame: 30 days
measure: World Health Organization Quality of Life BREF
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico VA Healthcare System
state: New Mexico
city: San Antonio
country: United States
facility: South Texas Veterans Healthcare System
state: Texas
Study officials:
References: