Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline
研究概览
简要总结
This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).
详细描述
Despite it's high prevalence, little is known about the pharmacological treatment of depression following Traumatic Brain Injury (TBI). This is because of a lack of randomized controlled studies in the treatment of post-TBI depression. This study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-TBI depression. It will also investigate metabolic changes and neural pathways associated with post-TBI depression and metabolic alterations after treatment through neuroimaging.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Closed head injury
- •Fulfill Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) IV criteria "Major Depressive Disorder"
- •18 years of age or older
- •Able to provide informed consent
- •Stable medical history
排除标准
- •History of Stroke, Encephalitis, Seizures, or any other pre-TBI neurological diseases
- •History of mental retardation
- •Alcohol or Substance dependence in the last 1 year
- •Inability to undergo MRI scan
- •Pregnancy
- •Current use of any psychotropic medications including any antidepressants, antipsychotics, anxiolytics, or sedative hypnotics
- •Poor response to escitalopram in the past
- •Acutely suicidal or requiring inpatient psychiatric hospitalization, as determined by the study psychiatrist
- •Good medication response to another antidepressant in the past
研究组 & 干预措施
Placebo
Daily for 12 weeks
干预措施: Placebo (Drug)
Escitalopram
Escitalopram 10 mg or 20 mg daily for 12 weeks
干预措施: Escitalopram (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline
时间窗: MADRS score at baseline
This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression. In this study the score was used as a continuous variable.
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: MADRS score at 12 weeks
This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression. In this study the score was used as a continuous variable.
次要结局
- Clinical Global Impression (CGI) - Severity at Baseline(Baseline)
- Satisfaction With Life (SWL)(12 weeks)
- Clinical Global Impression (CGI)- Improvement(at 12 weeks)
- Clinical Anxiety Scale (CAS)(12 weeks)
- Quality of Life (QWL)(At 12 weeks)
- Disability Rating Scale (DRS)(At 12 weeks)
- Mini Mental Status Exam (MMSE)(At 12 weeks)
研究者
Vani Rao, MD
Associate Professor
Johns Hopkins University