Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Hamilton-Depression Rating Scale (HDRS-24 Items)
研究概览
简要总结
This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.
It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning.
详细描述
This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of Dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase.
Flexible dosing to a maximum of 40 mg per day will be used. It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning. Blood cytokine levels will also be measured at weeks 0, 12, and 24 to determine their relationship to depressive symptoms and improvement.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients 18-65 years of age.
- •Patients with a Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnosis of dysthymic disorder.
- •Subject must be considered reliable.
- •Patients will have a total of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.
排除标准
- •Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.
- •Patients who plan to produce a pregnancy within the next 6 months, or patients who are pregnant or nursing women.
- •Patients who have a history of non-response to two or more sufficient trials of antidepressant medication (as defined in Table 1).
- •Patients with a principal diagnosis meeting DSM-IV criteria for:
- •Major Depressive Disorder, current
- •Bipolar Disorder or cyclothymia .Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified.
- •Anorexia Nervosa or Bulimia
- •Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol, excluding caffeine and tobacco.
- •Patients who have taken psychotropic medication or herbal preparations with putative psychotropic effects within 7 days prior to Visit
- •Patients taking a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) must have a washout period of 14 days prior to visit 2, and patients taking fluoxetine must have a washout period of at least 4 weeks prior to Visit
- •Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:
- •Report of having a specific plan for killing themselves
- •A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors)
- •A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of > 1 week's dose of medication.
- •Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic o neurologic disease, or any clinically significant laboratory abnormality.
- •Patients who lack the capacity to proved informed consent
- •50% or greater decrease in HDRS total score from visit 2 to visit 3 or a CGI-Improvement score of 1 ("very much improved") or 2 ("much improved") at Visit 3
- •Patients receiving CGI Improvement scores of 6 ("much worse") or 7 ("very much worse") for two consecutive visits will be withdrawn from the study.
- •Patients who meet criteria for Major Depressive Disorder at any time during the course of the study will be withdrawn from the study.
研究组 & 干预措施
escitalopram
Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
干预措施: Lexapro (escitalopram) (Drug)
Placebo
inactive comparator
干预措施: Lexapro (escitalopram) (Drug)
结局指标
主要结局
Hamilton-Depression Rating Scale (HDRS-24 Items)
时间窗: Baseline
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\>50% decrease) Remission (score\<=7)
次要结局
- Beck Depression Inventory (BDI)(Week 12)
- Clinical Global Impressions - Severity (CGI-S)(Baseline)