RECRUITING

Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)

Conditions

Mild Traumatic Brain Injury Post Concussive Syndrome (PCS)Posttraumatic Stress Disorder (PTSD)Polypharmacy Quetiapine Veterans

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy

Quick Facts

Study Start:2024-07-09

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06333990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. 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.

Inclusion Criteria

Exclusion 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.

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.
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.

Contacts and Locations

Study Contact

Muhammad R Baig, MD

CONTACT

210-617-5300

muhammad.baig@va.gov

Lizette Aviles, BS

CONTACT

361-277-5486

lizette.aviles@va.gov

Study Locations (Sites)

New Mexico VA Healthcare System

Albuquerque, New Mexico, 87108

United States

South Texas Veterans Healthcare System

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Foundation for Advancing Veterans' Health Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-09

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-07-09

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

Post Concussive Syndrome (PCS)
Posttraumatic Stress Disorder (PTSD)
Polypharmacy
Quetiapine
Veterans

Additional Relevant MeSH Terms

Mild Traumatic Brain Injury