ISRCTN14845583已完成4 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
niversity College London (UK)0 个研究点目标入组 360 人开始时间: 2015年2月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 or above
- •2. Gender: Male or female
- •3. Positive score of 10+ on GAD-7
- •4. Primary diagnosis of GAD as diagnosed on the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- •5. Failure to respond to NICE defined step 1 and 2 low intensity psychological interventions for GAD
排除标准
- •1. Inability to complete questionnaires due to insufficient English or cognitive impairment
- •2. Current major depression
- •3. Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD
- •4. Significant dependence on alcohol or illicit drugs
- •5. Comorbid psychotic disorder, bipolar disorder
- •6. Treatment with antidepressants in past 8 weeks or any high intensity psychological therapy within past 6 months
- •7. Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide.
- •8. Patients with poorly controlled epilepsy
- •9. Concurrent enrolment in another IMP (medication) trial
- •10. Women who are currently pregnant or planning pregnancy or lactating
- •11. Severe hepatic impairment
- •12. Patient on anti-coagulants
- •13. History of a bleeding disorder
研究者
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