Enhanced Identification of Very Early Response to Seroquel XR Added to an Antidepressant for the Treatment of Major Depressive Disorder With or Without Generalized Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report)
研究概览
简要总结
The proposed study is for a 6 week open-label clinical trial in which Seroquel XR is added to a selective serotonin reuptake inhibitor (SSRI) medication for the treatment of depressive and/or anxiety symptoms. Each subject will self-report changes in symptoms, functional impairment, etc. on a twice daily basis using a handheld computer (HHC) that transmits real-time symptoms reports to a central database. Each subject will be assessed in-person on a weekly or biweekly basis during the course of the study.
详细描述
This study is a 6-week open-label clinical trial in which Seroquel XR is added to an antidepressant medication for the treatment of MDD with or without comorbid generalized anxiety disorder. Patients who are currently experiencing a depressive episode that has not responded to an adequate trial of an antidepressant will be eligible to participate. During the course of augmentation treatment with Seroquel XR, each subject will regularly enter information on symptom severity and functional impairment into their handheld computer, and this information will be wirelessly transmitted to a central database.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder, currently depressed with or without a comorbid generalized anxiety disorder as determined by DSM-IV diagnostic criteria (confirmed using the MINI)
- •Outpatient status
- •17-item Hamilton Depression Rating Scale (HAM-D) score of ≥ 18
- •Treatment with any of the following antidepressant medications for the past 4 weeks at a minimum therapeutic dose
排除标准
- •Diagnosis of a past or current bipolar disorder
- •Current psychotic symptoms
- •Substance-induced mood disorder
- •Substance or alcohol dependence
- •Prominent current suicidal ideation as defined by a HAM-D item 3 (suicide item) score of ≥ 3
- •Current treatment with more than one antidepressant medication
- •Current treatment with an tricyclic (TCA) antidepressant or monoamine oxidase inhibitor (MAOI)
- •A patient with Diabetes Mellitus (DM)
结局指标
主要结局
The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report)
时间窗: Once Daily for 6 weeks
次要结局
- HADS (Hamilton Anxiety Depression Scale) VADIS(Once/twice Daily for 6 weeks)