Quetiapine in Melancholic Depression: an fMRI Study of Treatment-induced Changes in the Neurocircuitry of the Stress Response
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
研究概览
简要总结
In summary, the investigators propose to integrate fMRI assessments within a clinical trial of quetiapine XR in patients with melancholic depression in order to test the predictions that:
- quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
- successful treatment with quetiapine XR will be associated with normalization of limbic areas associated with increased salivary cortisol response to a stressful task as well as normalization on the emotional faces task differences in the melancholic group compared with healthy volunteers.
- successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task (i.e. there will be a diminished post-treatment mean AUC for cortisol secretion after the stress task compared to the pre-treatment AUC values in the patient group)
详细描述
Patients with major depression (N=20) will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be referred for an initial fMRI scanning session prior to the initiation of quetiapine XR. Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits). Ten demographically matched healthy subjects will receive the same fMRI investigations on two occasions in order to provide a healthy baseline comparison to permit interpretation of the patient findings (e.g., whether initial and final fMRI measures in patients are abnormal and to control for any adaptation to the task that may normally occur).
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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Melancolic depression patients
Patients with major depression will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing).
干预措施: Quetiapine (Drug)
结局指标
主要结局
quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features
时间窗: 8 weeks
Patients with major depression (N=20) will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be referred for an initial fMRI scanning session prior to the initiation of quetiapine XR. Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits).
次要结局
- normalization of limbic areas associated with increased salivary cortisol response to a stressful task(8 Weeks)
- successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task(8 weeks)
研究者
Erik Nelson
Adjunct Associate Professor
University of Cincinnati