A Randomized Clinical Trial of Quetiapine to Reduce Post Concussive Syndrome Polypharmacy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Neurobehavioral Symptom Inventory
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 diagnostic convention recommended by the VA/DoD requiring loss of consciousness, or a period of altered consciousness, or posttraumatic amnesia;
- •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.
排除标准
- •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 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)
- •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.
研究组 & 干预措施
Quetiapine
Quetiapine will be cross-tapered up to a maximum dose of 200 mg (as tolerated) as other standard of care medications are discontinued.
干预措施: Quetiapine Fumarate (Drug)
Treatment As Usual (TAU)
Participants in the TAU group will have doses adjusted over the same period as indicated by usual care criteria.
干预措施: TAU (Drug)
结局指标
主要结局
Neurobehavioral Symptom Inventory
时间窗: 2 weeks
A 22- item, self-report measure of symptoms of postconcussive symptoms severity for the preceding 2 week period. Items are scored on a 5-point scale, and a total score is obtained by summing the 22 symptom items, with higher scores indicate greater symptom severity. The total scores range from 0 - 88.
World Health Organization Disability Assessment Scale
时间窗: 30 days
A 12-item, self-report measure of functional disability for the preceding 30 days. Items are scored on a 5-point scale, and a total score is obtained by summing the 12 activities, with higher scores indicate greater disability. The total scores range from 0 - 48.
World Health Organization Quality of Life BREF
时间窗: 2 weeks
A 26- item, self-report measure to assess functioning and quality of life for the preceding 2 week period. It is a measure of conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, independence, and recreation.
次要结局
未报告次要终点