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临床试验/NCT01066143
NCT01066143终止不适用

Pharmacotherapy of Generalized Anxiety Disorder With Seroquel: Normalization of Brain Stress and Reward Function

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.

研究概览

简要总结

The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.

详细描述

Subjects will be recruited from clinic patients and known research subjects at McLean Hospital, as well as by advertisements in the media, flyers, and word of mouth. An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. Subjects will be also screened for drug use. If no obvious health problems are present, subjects will be scheduled for an evaluation. Upon arrival at the research unit, each subject will first complete a standardized interview schedule designed to obtain personal and background data such as age, marital status, socio-economic status, education, employment, etc. The Research Assistant will give subjects both verbal and written descriptions of the study procedures. After briefing subjects on the reasons for the research, subjects will be given the opportunity to ask questions. When they are ready, subjects will be asked to sign the written informed consent form approved by the Mclean Institutional Review Board (IRB). Functional magnetic resonance imaging scans to examine brain functioning will be obtained from GAD patients (N=30) at baseline and after 12 weeks. Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of written informed consent
  • Fluency in English
  • A diagnosis of GAD
  • No pregnancy
  • Right-handedness
  • Psychotropic medication-free at the start of the study

排除标准

  • Pregnancy or lactation
  • Any current DSM-IV-TR Axis I disorder
  • Any mental retardation or cognitive impairment that precludes informed consent
  • Known intolerance or lack of response to quetiapine fumarate
  • Substance or alcohol dependence at enrollment
  • Participation in another drug trial within 4 weeks prior enrollment
  • History of allergic reaction or hypersensitivity to Seroquel or Seroquel XR
  • History of prior Seroquel or other antipsychotic agents use
  • Contraindications to magnetic resonance imaging
  • Treatment with an effective medication for GAD

研究组 & 干预措施

Seroquel XR

Experimental

干预措施: Seroquel XR (Drug)

结局指标

主要结局

Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.

时间窗: 12 week

Changes in anxiety symptomatolgy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Igor Elman, MD

MD

Mclean Hospital

研究点 (1)

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