A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Remission and treatment response status by Hamilton Depression Rating Scale
研究概览
简要总结
The primary purpose of this study is to compare the short (12 week) and long-term (1-year) efficacy and the tolerability between stepwise psychopharmacotherapy and antidepressant monotherapy for 12 weeks in adult patients with major depressive disorders, stratified by the multimodal serum biomarker scores.
详细描述
This is prospective randomized controlled trials (RCT) to evaluate clinical impact of antidepressant monotherapy vs stepwise psychopharmacotherapy in patients with major depressive disorders, stratified by multimodal serum biomarker scores. Participants will be predicted treatment response based on the multimodal serum biomarker scores at baseline, will be categorized into good and poor treatment responders and then randomly assigned to two groups: stepwise pharmacotherapy group and antidepressant monotherapy group. The hypothesis is that in the good treatment responder, the depression remission will be achieved irrespective of treatment modality (stepwise pharmacotherapy or antidepressant monotherapy) group while in poor treatment responders, the treatment response of stepwise pharmacotherapy will be superior to those of antidepressant monotherapy.
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, Outcomes Assessor)
盲法说明
partial masking(participants, care providers, outcome assessor are not aware of treatment response scores in spite of opened status for prescribed information (mono vs step)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 to 65 years
- •Diagnostic and Statistical Manual of Mental Disorders-IV criteria for major depressive disorder by study psychiatrists
- •Score≥17 on Hamilton Depression Rating Scale-17
- •With ability to understand the objective of the study and sign informed consent
- •Initiation of an antidepressant treatment for the current episode or no psychotropics excluding sleep pills or benzodiazepines within 1 month of participation
排除标准
- •Current or lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or other psychotic disorders
- •current major depressive disorder with psychotic features
- •History of organic psychosis, epilepsy, or seizure disorder
- •Current anorexia nervosa or obsessive compulsive disorder
- •Unstable or uncontrolled medical condition
- •Unable to complete the psychiatric assessment or comply with the medication regimen due to a severe physical illness
- •History of anticonvulsant treatment
- •Electroconvulsive therapy for the current depressive episode
- •Hospitalization for any psychiatric diagnosis except depressive disorder (e.g., alcohol/drug dependence)
- •severly high risk of suicide, self-harm or homicide by investigator's assessment
- •Pregnant or breastfeeding
- •lack of treatment information on the current depressive episode
研究组 & 干预措施
Good responder group-stepwise pharmacotherapy group
Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then good responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group.
In the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.
干预措施: stepwise pharmacotherapy (Drug)
Good responder group-antidepressant monotherapy group
Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then good responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group.
In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.
干预措施: antidepressant monotherapy group (Drug)
Poor responder group-stepwise pharmacotherapy group
Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then poor responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group.
In the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.
干预措施: stepwise pharmacotherapy (Drug)
Poor responder group-antidepressant monotherapy group
Using multimodal serum biomarker scores, patients will be divided into good/poor responder. Then poor responder group will be randomized into stepwise pharmacotherapy group vs antidepressant monotherapy(escitalopram) group.
In the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.
干预措施: antidepressant monotherapy group (Drug)
结局指标
主要结局
Remission and treatment response status by Hamilton Depression Rating Scale
时间窗: From baseline to 12 week, 1 year
Remission defined by total scores of Hamilton Depression Rating Scale (0-52; higher score indicates severe symptom) ≤7 and treatment response defined as ≥50% decrease in the baseline total scores of Hamilton Depression Rating Scale after stepwise psychopharmacotherapy or antidepressant monotherapy
次要结局
- The changes of Hospital Anxiety and Depression Scale total score, depression subscore, anxiety subscore(From baseline to 12 week, 1 year)
- The changes of Clinical Global Impression-severity and improvement score(From baseline to 12 week, 1 year)
- The changes of Social and Occupational Functioning Assessment Scale score(From baseline to 12 week)
- The changes of EuroQol-5 Dimension score(From baseline to 12 week, 1 year)
- The changes of Hamilton Rating Scale for Depression total score(From baseline to 12 week, 1 year)
- The changes of Brief Psychiatric Rating Scale suicide item score(From baseline to 12 week, 1 year)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period(First dose of study drug to last dose of study drug in the 26-week Treatment Period and 1 year after baseline)
研究者
Jae-Min Kim
Professor
Chonnam National University Hospital