Kingslake Jonathan, Dias Rebecca, Dawson Gerard R, Simon Judit, Goodwin Guy M, Harmer Catherine J, Morriss Richard, Brown Susan, Guo Boliang, Dourish Colin T, Ruhé Henricus G, Lever Anne G, Veltman Dick J, van Schaik Anneke, Deckert Jürgen, Reif Andreas, Stäblein Michael, Menke Andreas, Gorwood Philip, Voegeli Géraldine, Pérez Victor, Browning Michael
P1vital Products Ltd, Howbery Park, Wallingford, Oxfordshire, UK.
P1vital Ltd., Howbery Park, Wallingford, Oxfordshire, UK.
Trials. 2017 Nov 23;18(1):558. doi: 10.1186/s13063-017-2247-2.
Antidepressant medication is commonly used to treat depression. However, many patients do not respond to the first medication prescribed and improvements in symptoms are generally only detectable by clinicians 4-6 weeks after the medication has been initiated. As a result, there is often a long delay between the decision to initiate an antidepressant medication and the identification of an effective treatment regimen. Previous work has demonstrated that antidepressant medications alter subtle measures of affective cognition in depressed patients, such as the appraisal of facial expression. Furthermore, these cognitive effects of antidepressants are apparent early in the course of treatment and can also predict later clinical response. This trial will assess whether an electronic test of affective cognition and symptoms (the Predicting Response to Depression Treatment Test; PReDicT Test) can be used to guide antidepressant treatment in depressed patients and, therefore, hasten treatment response compared to a control group of patients treated as usual.
METHODS/DESIGN: The study is a randomised, two-arm, multi-centre, open-label, clinical investigation of a medical device, the PReDicT Test. It will be conducted in five European countries (UK, France, Spain, Germany and the Netherlands) in depressed patients who are commencing antidepressant medication. Patients will be randomised to treatment guided by the PReDicT Test (PReDicT arm) or to Treatment as Usual (TaU arm). Patients in the TaU arm will be treated as per current standard guidelines in their particular country. Patients in the PReDicT arm will complete the PReDicT Test after 1 (and if necessary, 2) weeks of treatment. If the test indicates non-response to the treatment, physicians will be advised to immediately alter the patient's antidepressant therapy by dose escalation or switching to another compound. The primary outcome of the study is the proportion of patients showing a clinical response (defined as 50% or greater decrease in baseline scores of depression measured using the Quick Inventory of Depressive Symptoms - Self-Rated questionnaire) at week 8. Health economic and acceptability data will also be collected and analysed.
This trial will test the clinical efficacy, cost-effectiveness and acceptability of using the novel PReDicT Test to guide antidepressant treatment selection in depressed patients.
ClinicalTrials.gov, ID: NCT02790970 . Registered on 30 March 2016.
抗抑郁药物常用于治疗抑郁症。然而，许多患者对首次开具的药物没有反应，症状改善通常在开始用药4 - 6周后才被临床医生察觉。因此，从决定开始使用抗抑郁药物到确定有效的治疗方案之间往往有很长的延迟。先前的研究表明，抗抑郁药物会改变抑郁症患者情感认知的细微指标，比如对面部表情的评估。此外，抗抑郁药物的这些认知效应在治疗早期就很明显，并且还能预测后期的临床反应。本试验将评估一种情感认知和症状的电子测试（预测抑郁症治疗反应测试；PReDicT测试）是否可用于指导抑郁症患者的抗抑郁治疗，从而与按常规治疗的对照组患者相比加快治疗反应。
方法/设计：本研究是一项针对医疗设备PReDicT测试的随机、双臂、多中心、开放标签的临床研究。研究将在五个欧洲国家（英国、法国、西班牙、德国和荷兰）对开始使用抗抑郁药物的抑郁症患者进行。患者将被随机分为接受PReDicT测试指导的治疗组（PReDicT组）或常规治疗组（TaU组）。TaU组的患者将按照其所在国家的现行标准指南进行治疗。PReDicT组的患者将在治疗1周后（如有必要，2周后）完成PReDicT测试。如果测试表明对治疗无反应，将建议医生立即通过增加剂量或换用另一种药物来改变患者的抗抑郁治疗方案。该研究的主要结局是在第8周时显示出临床反应的患者比例（定义为使用抑郁症状快速自评问卷测量的抑郁基线评分降低50%或更多）。还将收集和分析健康经济学及可接受性数据。
本试验将测试使用新型PReDicT测试指导抑郁症患者抗抑郁治疗选择的临床疗效、成本效益和可接受性。
ClinicalTrials.gov，标识符：NCT02790970。于2016年3月30日注册。
