EUCTR2014-004077-16-GB进行中（未招募）1 期
A Phase IV randomised controlled trial of the selective serotonin reuptake inhibitor Sertraline versus Cognitive Behavioural Therapy for anxiety symptoms in people with Generalised Anxiety Disorder (GAD) who have failed to respond to low intensity psychological interventions as defined by the NICE GAD guidelines - ToSCA: Trial of Sertraline versus CBT for generalised Anxiety
niversity College London Joint Research Office0 个研究点目标入组 5 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
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
入选标准
- •Aged 18 or above
- •Gender: male or female
- •Positive score of 10+ on GAD-7
- •Primary diagnosis of GAD as diagnosed on the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- •Failure to respond to NICE defined step 1 and 2 low intensity interventions for GAD
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Inability to complete questionnaires due to insufficient English or cognitive impairment
- •Current major depression
- •Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD
- •Significant dependence on alcohol or illicit drugs
- •Comorbid psychotic disorder, bipolar disorder
- •Treatment with antidepressants in past 8 weeks or any high intensity psychological therapy within past 6 months
- •Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide.
- •Patients with poorly controlled epilepsy
- •Concurrent enrolment in another IMP (medication) trial
- •Women who are currently pregnant or planning pregnancy or lactating
- •Severe hepatic impairment
- •Patient on anti-coagulants
- •History of a bleeding disorder
研究者
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Trial of Sertraline versus CBT for generalised AnxietyTopic: Mental HealthSubtopic: AnxietyDisease: AnxietyMental and Behavioural DisordersISRCTN14845583niversity College London (UK)360
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