Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.
研究概览
简要总结
This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.
详细描述
An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. If no obvious counterindications are present, subjects will be scheduled for a screening visit. After briefing the subjects on the reasons for the research, they will be given an opportunity to read the Informed Consent Form, approved by the Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.
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
- •Provision of written informed consent
- •Fluency in English
- •A diagnosis of PTSD
- •No pregnancy
- •Right-handedness
排除标准
- •Pregnancy or lactation
- •Any cognitive impairment that precludes informed consent
- •Known intolerance or lack of response to Seroquel
- •Previous enrollment or randomization of treatment in the present study
- •Participation in another drug trial within 4 weeks prior enrollment into this study
- •Patients with Diabetes Mellitus
- •History of allergic reaction or hypersensitivity to Seroquel
- •Contraindications to magnetic resonance imaging
- •Treatment with an effective medication for PTSD
研究组 & 干预措施
Seroquel
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
干预措施: Seroquel (Drug)
结局指标
主要结局
Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.
时间窗: 8 weeks
We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed
次要结局
未报告次要终点
研究者
Igor Elman
MD
Cambridge Health Alliance