EUCTR2012-001779-35-GB进行中（未招募）不适用
The effects of pregabalin augmentation of antidepressant drug on neuro-cognitive functioning in patients with generalized anxiety disorder
niversity of Southampton0 个研究点开始时间: 2012年11月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria
- •Male or female patients aged between 18-70 years
- •DSM-IV diagnosis of generalized anxiety disorder (GAD)
- •Historical evidence of treatment of current symptoms with an SSRI or SNRI for at least 6 weeks
- •At least ‘moderately ill’ on the Clinical Global Impression of Severity (score of 4 or more)
- •Anxiety symptoms of at least moderate severity (i.e. 24 or more on the Hamilton Anxiety Scale)
- •Depressive symptoms of not more than mild severity (i.e. less than 20 on the MADRS)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Male or female patients aged less than 18 or more than 70 years
- •Primary diagnosis other than GAD
- •No historical evidence of treatment of current symptoms with an SSRI or SNRI for at least 6 weeks
- •Less than moderately ill on the Clinical Global Impression of Severity (CGI-S score of 3 or less)
- •Anxiety symptoms of less than moderate severity (i.e. 23 or less on the Hamilton Anxiety Scale)
- •Depressive symptoms of more than mild severity (i.e. 20 or more on the MADRS)
- •A primary diagnosis of an alcohol or substance use disorder
- •DSM-IV diagnosis of antisocial personality disorder, according to completion of the MINI
- •Pregnant/breastfeeding women.
- •Patients with a primary substance abuse or dependence disorder will be excluded from participating in the study, but those with secondary substance abuse (not dependence) could be included, providing that it had temporally arisen during the ‘index episode’ of GAD, that the symptoms were regarded as being secondary to the GAD, and that the nature of the substance use was such that treatment with an SSRI or SNRI was not inadvisable.
- •Patients with coexisting depressive symptoms could be included, if the patient and the doctor considered GAD was the primary diagnosis based on symptom severity and distress. However if the patient scored 20 or more on the Montgomery-Asberg
- •Depression Rating Scale (MADRS) (Montgomery & Asberg, 1979) they would be excluded from participation in the study. The MINI includes a module to identify antisocial personality disorder, and patients who meet the criteria for this condition will be excluded from the study.
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