Improving Quality of Life and Social Functionality With Escitalopram in the Treatment of Major Depressive Disorder With Anxiety Symptom
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 主要终点
- Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56
研究概览
简要总结
The purpose of this study is to evaluate the impact of escitalopram on quality of life and social functionality in patients with major depressive disorder with anxiety symptom.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center, prospective (a study in which the participants are identified and then followed forward in time for the outcome of the study), single-arm (all participants receiving one intervention) study. Approximately 260 participants will be enrolled in this study. This study consists of two phases: screening phase and treatment phase. In the treatment phase, participants will receive escitalopram for 8 weeks: escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The total study duration will be approximately 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of major depressive disorder according to the American Psychiatric Association's Diagnostic and Statistical Manual-IV, Text Revision (DSM-IV-TR) diagnostic criteria
- •Minimum scores of 9 on Sheehan Disability Scale
- •Minimum scores of 14 on Hamilton Anxiety Scale
排除标准
- •History of primary or comorbid diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder, or dementia
- •Presence of unstable serious illness and/or has a clinically significant renal or hepatic impairment, seizure disorders or any other disease which may be detrimental to the participant or the study
- •Participant who have continuously taken psychoactive substances, antidepressants, anxiolytics, Monoamine oxidase inhibitors, psychoactive herbal remedies, lithium, electroconvulsive therapy, carbamazepine in the past 2 weeks before the baseline visit
- •Diagnosis of major depressive disorder who currently require treatment systematically within past 2 months from baseline
- •Receiving pharmacological treatment, which is disallowed in the current approved Chinese summary of product characteristics for escitalopram
研究组 & 干预措施
Escitalopram
Participants will receive escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
干预措施: Escitalopram (Drug)
结局指标
主要结局
Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56
时间窗: Baseline, Day 14, Day 28, Day 42, and Day 56
SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from "0 = unimpaired" to "30 = highly impaired". Higher scores indicate worsening.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56
时间窗: Baseline, Day 14, Day 28, Day 42 and Day 56
Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from "1 = very poor" to "5 = very good". The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening.
次要结局
- Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56(Day 7, Day 14, Day 28, Day 42 and Day 56)
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56(Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56)
- Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56(Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56)
- Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56(Day 7, Day 14, Day 28, Day 42 and Day 56)
- Treatment Improvement Rate at the End of Week 1 and Week 2(Week 1 and Week 2)
- Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56(Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56)
- Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56(Day 7, Day 14, Day 28, Day 42 and Day 56)
- Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56(Day 7, Day 14, Day 28, Day 42 and Day 56)