ISRCTN16993990进行中（未招募）4 期
PrEgabalin for Treatment Resistant generalised Anxiety disorder (PETRA) a double-blind randomised controlled clinical trial to evaluate the addition of pregabalin to primary care patients who have not responded or partially responded to treatment with antidepressants
niversity College London0 个研究点目标入组 498 人开始时间: 2023年9月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 498
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. Meeting ICD-11 criteria for generalised anxiety disorder using the revised clinical interview schedule (CIS-R)
- •2. Scoring =12 on the CIS-R total score
- •3. Age 18-74 years (upper age limit to ensure the validity of our measures)
- •4. Currently taking an SSRI, SNRI or mirtazapine in BNF recommended doses for a minimum of 8 weeks prior to randomisation
- •5. Treatment with at least one other antidepressant before their current antidepressant
排除标准
- •1. Currently taking pregabalin or use within the previous 1 month (i.e. wash-out of 1 month required)
- •2. Taking regular antipsychotics
- •3. Have bipolar disorder, psychosis, or alcohol misuse
- •4. Current or recent opiate dependence where there is a risk of pregabalin abuse
- •5. Current use of opiates with a daily dose of >15 morphine milligram equivalents
- •6. Creatinine clearance <30 ml/min
- •7. Requirement to use home oxygen machines
- •8. Experience breathlessness and score =3 on the MRC Dyspnoea scale (‘Stops for breath after walking about 100 metres or after a few minutes on the level’ or ‘Too breathless to leave the house or breathless when dressing or undressing’)
- •9. Regular daily use of z drugs >3.75 mg zopiclone or >10mg zolpidem
- •10. Regular daily use of benzodiazepines or regular night-time use >10mg diazepam or equivalent.
- •11. Currently receiving or about to receive psychological treatment
- •12. Pregnancy, planned pregnancy and women who are breastfeeding
- •13. Unable to complete self-administered scales in English (some scales are not validated in other languages)
- •14. Taking part in another CTIMP
研究者
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