Escitalopram in the Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- HAM-D (Hamilton Rating Scale for Depression)
研究概览
简要总结
The purpose is to determine if: 1) Escitalopram treatment will be associated with less oral corticosteroid use than placebo in outpatients with severe asthma and moderate or severe major depressive disorder (MDD). 2) Escitalopram treatment will be associated with greater improvement in asthma symptoms than placebo in outpatients with severe asthma and moderate or severe MDD. 3) Escitalopram treatment will be associated with greater depressive symptom remission rates than placebo in outpatients with severe asthma and moderate or severe MDD.
详细描述
Primary Aim
- Determine if escitalopram treatment is associated with less oral corticosteroid use for asthma symptom control than placebo in asthma outpatients with moderate or MDD.
Secondary Aims
- Determine if escitalopram treatment is associated with greater improvement in asthma symptoms than placebo in outpatients with severe asthma and moderate or severe MDD.
- Determine if escitalopram treatment is associated with greater depressive symptom remission rates than placebo in outpatients with severe asthma and moderate or severe MDD.
Background/Significance
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current HAM-D score of ≥ 20
- •Patients with severe asthma (defined as asthma requiring three or more course of oral corticosteroids in the past year).
- •No changes in asthma medications, oral corticosteroid use, or treatment for respiratory tract infections in the past week
- •Needs to have taken ≥ 3 courses of oral corticosteroids, for asthma, in the past 12 months.
- •Both male and female
- •English- or Spanish-speaking
排除标准
- •Current substance or alcohol abuse/dependence
- •MDD with psychotic features (delusions, hallucinations, disorganized thought processes)
- •Bipolar disorder
- •Schizophrenia or schizoaffective disorder
- •Substance-induced mood disorder and mood disorder secondary to a general medical condition
- •Mental retardation or other severe cognitive impairment
- •Prison or jail inmates
- •Pregnant or nursing women or women of childbearing age who will not use The University of Texas Southwestern Medical Center - Institutional Review Board (UTSW IRB) approved methods of birth control or abstinence during the study
- •Treatment-resistant depressed persons defined as having failed two adequate trials of antidepressants
- •Current antipsychotic or antidepressant therapy or psychotherapy
- •Initiation of other psychotropic medications or psychotherapy within past 2 weeks (e.g., anxiolytics, hypnotics)
研究组 & 干预措施
Placebo
Placebo Matching Escitalopram given orally daily (for a 12-week duration).
干预措施: Placebo (Drug)
Escitalopram
Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
干预措施: Escitalopram (Drug)
结局指标
主要结局
HAM-D (Hamilton Rating Scale for Depression)
时间窗: Up to 12 weeks
The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).
ACQ (Asthma Control Questionnaire)
时间窗: Up to 12 weeks
The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).
IDS-SR (Inventory of Depressive Symptomatology - Self-Report)
时间窗: Up to 12 weeks
The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).
次要结局
未报告次要终点
研究者
Sherwood Brown
Principal Investigator, MD/PhD
University of Texas Southwestern Medical Center