A Randomized, Double-blind, Comparison of the Efficacy and Safety of Escitalopram Plus PS128 to Escitalopram in the Acute Treatment of Patients With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Depression severity by the change of 17-item Hamilton Rating Scale for Depression (HAMD-17) total scores
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of escitalopram plus PS128 to escitalopram in the acute treatment of patients with major depressive disorder.
详细描述
In this 6-week, double-blind, fixed-dose study, patients with major depressive disorder are randomly assigned to escitalopram (10 mg daily) plus PS128 (a psychobiotic) (300 mg two times daily, equivalent to 3 ×1010 CFU two times daily) or escitalopram (10 mg daily) groups. The rating scales and instrument, including Clinical Global Impression-Severity, 17-item Hamilton Rating Scale for Depression, Hamilton Anxiety Rating Scale, Global Assessment of Functioning, Heart Rate Variability, Depression and Somatic Symptoms Scale, Work and Social Adjustment Scale, Short form 36 and Pittsburgh Sleep Quality Index, are used to measure treatment outcomes at weeks 0, 1, 2, 3, 4, 5, and 6. UKU Side Effect Rating Scale and Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome are used to measure side effects. Generalized estimating equations model will be used to analyze the differences between two groups with respect to efficacy and safety measures on time after adjusting for baseline severity, sex, age and age at onset of illness.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive disorder
- •the score of the 17-item Hamilton Rating Scale for Depression (HAMD-17) was 18 or higher.
- •washout of antipsychotics at least 3 days
- •written informed consents
- •Not taking fluoxetine at least one month before admission.
排除标准
- •History of schizophrenia, schizoaffective disorder or organic mental disorders.
- •comorbid with substance abuse/dependence in the past 6 months.
- •with psychotic features
- •treatment-resistant depression or receiving electroconvulsive therapy.
- •History of serious adverse events to escitalopram
- •female subjects with pregnancy or lactation.
- •severe physical illness
- •receiving antibiotics treatment in the past two weeks.
- •taking products with probiotics.
研究组 & 干预措施
escitalopram plus128
escitalopram (10 mg daily) plus PS128(a psychobiotic) (300 mg two times daily, equivalent to 3 ×1010 CFU two times daily)
干预措施: Lactobacillus plantarum PS128 (Dietary Supplement)
escitalopram
10 mg/d of escitalopram
干预措施: Lactobacillus plantarum PS128 (Dietary Supplement)
结局指标
主要结局
Depression severity by the change of 17-item Hamilton Rating Scale for Depression (HAMD-17) total scores
时间窗: Time Frame: The HAMD-17 was rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).
17-item Hamilton Rating Scale for Depression (HAMD-17) is widely used in clinical setting to evaluate depression symptoms in the past week. Higher total HAMD-17 scores (ranging from 0 to 52) indicate more severe depression.
次要结局
- Change of body weights(Time Frame: Body weights were assessed at baseline and week 6(or on early termination).)
- Change of blood pressure(Time Frame: Blood pressure were checked at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination).)
- depression and somatic symptoms evaluation(The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).)
- Change of pulse rate(Time Frame: Pulse rates were checked at baseline and at weeks 1, 2, 3, 4, and 6 (or on early termination).)
- change of fasting glucose.(Time Frame: laboratory test mentioned above were assessed at baseline and week 6(or on early termination.)
- change of lipid profiles.(Time Frame: laboratory test mentioned above were assessed at baseline and week 6(or on early termination).)
- Assessments of heart rate variability(Time Frame: Heart rate variability was assessed at baseline and week 6)
- Function evaluation(The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).)
- Change of body mass index (BMI)(Time Frame: BMI was assessed at baseline and week 6(or on early termination).)
- Gastrointestinal Symptoms evaluation(The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).)
- Sleep Quality evaluation: The Pittsburgh Sleep Quality Index (PSQI)(The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).)
- change of work and social adjustment(The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).)
- Clinical severity by Clinical Global Impression-Severity (CGI-S)(The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).)
- Assessments of safety for general adverse events(The scales were rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination).)
- Change of ECG QT Interval(Time Frame: ECG were assessed at baseline and week 6 (or on early termination).)
- change of liver function(Time Frame: laboratory test mentioned above were assessed at baseline and week 6 (or on early termination).)
- change of renal function(Time Frame: laboratory test mentioned above were assessed at baseline and week 6 (or on early termination).)
- Assessments of quality of life(Time Frame: Medical Outcomes Study Short-Form 36 was assessed at baseline and week 6)
研究者
Ching-Hua Lin, MD, PhD
Chief of Adult Psychiatry
Kaohsiung Kai-Suan Psychiatric Hospital