NCT02122393已完成3 期
A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory
研究概览
简要总结
Th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal 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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with an infant > 2 months and < 8 months of age
- •Infant born after a full-term pregnancy
- •Infant born with no congenital abnormalities
- •Diagnosis of depression with postnatal onset according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV).
排除标准
- •positive serum pregnancy test;
- •concurrent psychiatric disorder (excepting co-morbid anxiety);
- •recent history of antidepressant usage (within the last month);
- •history of major allergy or drug allergy;
- •history of substance abuse;
- •prior non-response to sertraline, or prior non-response to adequate trials of two selective serotonin reuptake inhibitors (SSRIs);
- •predisposition to headache, migraine or nausea;
- •tobacco habit in excess of 10 cigarettes per day;
- •caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per day;
- •ongoing dental work;
- •extreme levels of depression (psychotic);
- •suicidal intent;
- •participation in any medical trial within the previous three months;
研究组 & 干预措施
Sertraline
Active Comparator
干预措施: Sertraline (Drug)
Cognitive Behavioural Therapy
Active Comparator
干预措施: Cognitive Behavioural Therapy (Behavioral)
Combined Therapy
Active Comparator
干预措施: Sertraline (Drug)
Combined Therapy
Active Comparator
干预措施: Cognitive Behavioural Therapy (Behavioral)
结局指标
主要结局
Beck Depression Inventory
时间窗: 24 weeks
次要结局
- Parenting Stress Index(24 weeks)
- Beck Anxiety Inventory(24 weeks)
研究者
Jeannette Milgrom
Professor
University of Melbourne
研究点 (1)
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