Lithium Augmentation for Hyperarousal Symptoms of Traumatic Stress Disorder: Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Udvalg for Kliniske Undersogelser Side Effect Rating Scale
研究概览
简要总结
The purpose of this study is to explore the effectiveness of adding lithium carbonate (lithium) to treatment for combat-related post traumatic stress disorder in combat veterans. The goal of this study is to establish that lithium is a practical and tolerable treatment option for veterans with combat posttraumatic stress disorder.
详细描述
Few evidence-based treatment options exist for patients with posttraumatic stress disorder inadequately responsive to standard medication treatments, such as psychopharmacology with serotonin specific reuptake inhibitors. Although many agents have been studied in the management of posttraumatic stress disorder, including antidepressants, mood stabilizers, and atypical antipsychotics, augmentation of existing treatments with lithium remains almost wholly unexplored. Lithium augmentation may represent a worthwhile treatment option in light of its broad clinical utility, including reported clinical benefits for aggression, suicidality, and mood; its apparent effects on mediotemporal and prefrontal brain areas; and the neurobiology of posttraumatic stress disorder.
Primary Aim:
Establish the safety and tolerability of lithium augmentation of psychopharmacological treatment as usual for combat veterans with posttraumatic stress disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Combat Veterans seeking treatment at the Denver Veterans Affairs Medical Center. Subjects must be between the ages of 18-50 years old, have a diagnosis of Posttraumatic Stress Disorder and assessed with a Clinician Administered Posttraumatic Stress Disorder Scale scoring greater than 15 on the Clinician Administered Posttraumatic Stress Disorder Scale -D. Subjects may have a history mild traumatic brain injury. Subjects must also have a stable medical condition to be considered for the study. Both males and females will be included, and no exclusions will be made for race or ethnicity.
排除标准
- •Subjects with substance dependence disorder less than two months prior to study enrollment; history of bipolar, psychotic and/or cognitive disorders; history of moderate-to-severe traumatic brain injury; seizure disorder; sensitivity to lithium or contraindications to lithium treatment; will not be included in this study.
- •Subjects currently enrolled in other intervention studies that may affect the outcome of this study, or where this study may affect the outcome of the other study, will not be included until the subject has completed their participation in the other study.
- •Women, who are pregnant, suspect that they are pregnant, or planning to become pregnant will not be enrolled into the study.
- •Subjects declared incompetent by the Veterans Health Administraytion or other legal authority will not be included for participation in this study. Additionally, research team members involved in the consenting process of the study will not enroll subjects whom appear incompetent to consent. Recruited subjects unable to comprehend the nature of the study, their involvement & possible risks, described to them during the consent/enrollment process, will not be allowed to participate in the study for the respect of the volunteering subject, their safety, & to ensure that volunteering subjects do not experience any coercion to participate in this study.
研究组 & 干预措施
Lithium Augmentation
Open-label trial - active treatment
干预措施: Lithium Carbonate (Drug)
结局指标
主要结局
Udvalg for Kliniske Undersogelser Side Effect Rating Scale
时间窗: Baseline & Week 8
This is a comprehensive side effect rating scale designed to capture the side effects associated with psychotropic medications in both clinical trials and routine clinical use. Its reliability and validity are well established and it has been used in a variety of clinical trials.Forty-eight items are grouped into four categories: Psychic, Neurological, Autonomic, and Other. Causal relationship to each item is rated as impossible, possible, or probable.
次要结局
- Clinician Administered Posttraumatic Stress Disorder Scale(Baseline and weeks 1-8)
- Beck Scale for Suicide Ideation(Baseline and weeks 1-8)