NCT01109693已完成4 期
Strategic Use of New Generation Antidepressants for Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,011
- 试验地点
- 2
- 主要终点
- Observer-rated depression severity (PHQ-9)
研究概览
简要总结
The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition [DSM-IV]) in the preceding month
- •age 25-75
- •starting treatment with sertraline clinically indicated
- •tolerability to sertraline 25 mg/d ascertained
- •can understand and sign informed consent form
- •can be contacted by telephone for symptom severity and adverse events
排除标准
- •have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month
- •history of schizophrenia, schizoaffective disorder or bipolar disorder
- •current dementia, borderline personality disorder, eating disorder or substance dependence
- •physical disease interfering with sertraline or mirtazapine treatment
- •allergy to sertraline or mirtazapine
- •terminal physical illness
- •currently pregnant or breast-feeding
- •high risk of imminent suicide
- •requiring compulsory admission
- •expected to change doctors within 6 months
- •cohabiting relatives of research staff
- •cannot understand Japanese
研究组 & 干预措施
Continue sertraline
Active Comparator
Continue sertraline at the dosage at 3 weeks
干预措施: Sertraline (Drug)
Augment with mirtazapine
Active Comparator
Add mirtazapine to sertraline
干预措施: Sertraline (Drug)
Augment with mirtazapine
Active Comparator
Add mirtazapine to sertraline
干预措施: Mirtazapine (Drug)
Switch to mirtazapine
Active Comparator
Stop sertraline and switch to mirtazapine
干预措施: Mirtazapine (Drug)
结局指标
主要结局
Observer-rated depression severity (PHQ-9)
时间窗: 9 weeks
Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview.
次要结局
- Self-rated depression severity (BDI-II)(9 weeks)
- Global rating of side effects (FIBSER)(9 weeks)
研究者
Toshiaki A. Furukawa
Professor
Kyoto University
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Developing New Clinical Management StrategiesMajor Depressive DisorderNCT02082392New York State Psychiatric Institute3
已完成
4 期
Contact: Developing New Clinical Management StrategiesMajor Depressive DisorderNCT03812588New York State Psychiatric Institute29
招募中
1 期
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)SequestraDepressionNCT05814640First Affiliated Hospital of Chongqing Medical University520
终止
不适用
Pharmacogenetic and Antidepressant Treatment in ElderlyDepressionNCT02856477Centre Hospitalier Universitaire de Besancon28
已完成
不适用
Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in KoreaMajor DepressionNCT04446039Pfizer370,212