NCT00681668终止2 期
The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The Change in the Hamilton Rating Scale for Depression (HAM-D)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed informed consent.
- •Female patients with severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points
排除标准
- •Woman with pre-existing psychotic disorder
- •Patients with alcohol or substance abuse or dependence
- •Patients who pose an imminent risk of suicide or danger to self or others
研究组 & 干预措施
Quetiapine Fumarate 150 - 800mg
Experimental
Quetiapine 150-800mg
干预措施: Quetiapine (Drug)
结局指标
主要结局
The Change in the Hamilton Rating Scale for Depression (HAM-D)
时间窗: Baseline Day 1 to final visit 28 weeks
HAM-D is a 17-21 item observer-rated scale to assess presence and severity of depressive states. 9 items are scored 0-4, whereas the further 8 are scored 0-2, as these represent variables which do not lend themselves to quantitative rating (0=absent; 1=doubtful or slislight; 2=clearly present). Higher scores indicate higer depressive state
次要结局
- Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)(Baseline Day 1 to final visit 28 weeks)
- Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)(Baseline Day 1 to final visit 28 weeks)
- Electrocardiogram (ECG), Vital Signs, Laboratory(Baseline Day 1 to final visit 28 weeks)
研究者
研究点 (1)
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