Qurashi Inti, Chu Simon, Drake Richard, Hartley Victoria, Chaudhry Imran, Deakin J F W, Husain Nusrat
Ashworth Hospital, Mersey Care NHS Foundation Trust, Maghull, UK.
2Faculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
Pilot Feasibility Stud. 2019 Jun 17;5:79. doi: 10.1186/s40814-019-0462-1. eCollection 2019.
Clozapine-induced hypersalivation (CIH) is a common side effect of clozapine treatment and is disliked by clozapine patients, potentially threatening adherence to clozapine treatment. We proposed a trial of alternative medications, hyoscine and glycopyrrolate, for the treatment of CIH and the primary objective of the feasibility study was to assess the recruitment and retention of community clozapine patients as well as assess the metrics of the primary hypersalivation measure.
This 11-month trial took place in two NHS trusts in northwest UK. Participants were community-dwelling clozapine patients aged 18-65 years who were suffering from CIH, and were recruited from community mental health clinics. They were randomised using a telephone randomisation service to receive either hyoscine (1 week at 0.6 mg daily, 3 weeks at 0.9 mg daily), glycopyrrolate (1 week at 2 mg daily, 3 weeks at 3 mg daily) or placebo. Participants and investigators were blinded to which study arm the participants had been randomised to. We collected data on salivation levels and side effects on a weekly basis and also assessed cognition at the beginning and end of the trial. We also interviewed a sample of participants after the trial to gather information on their experience of having taken part.
One hundred and thirty-eight potential participants agreed to being contacted by researchers about participation in the trial and of these, 29 participants were randomised. Of these, four participants exited the trial before taking any trial medication, and two participants left the study owing to concerns of side effects. Data from four participants was missing, and complete data was available for 19 participants who completed the trial. The mean recruitment rate overall was 1.3 participants per site per month, and the overall retention rate was 76%. Interview data suggested that participants' experiences of trial participation were overwhelmingly positive.
The feasibility study demonstrated that a trial of alternative medications in the treatment of CIH is feasible; patients were willing to be randomised to the trial and retention rate was high.
ClinicalTrials.gov, NCT02613494, registered 24 November 2015.
氯氮平引起的流涎（CIH）是氯氮平治疗常见的副作用，且为氯氮平治疗患者所厌恶，这可能会威胁到氯氮平治疗的依从性。我们开展了一项针对替代药物——东莨菪碱和格隆溴铵——治疗CIH的试验，该可行性研究的主要目的是评估社区氯氮平治疗患者的招募及留存情况，并评估主要流涎指标。
这项为期11个月的试验在英国西北部的两个国民保健服务信托机构进行。参与者为年龄在18 - 65岁、患有CIH的社区氯氮平治疗患者，从社区精神健康诊所招募。使用电话随机服务将他们随机分组，分别接受东莨菪碱（每日0.6毫克，为期1周；每日0.9毫克，为期3周）、格隆溴铵（每日2毫克，为期1周；每日3毫克，为期3周）或安慰剂治疗。参与者和研究者均不知道参与者被随机分配到了哪个研究组。我们每周收集唾液分泌水平和副作用的数据，并在试验开始和结束时评估认知情况。试验结束后，我们还对部分参与者进行了访谈，以收集他们参与试验的体验信息。
138名潜在参与者同意研究人员就参与试验事宜与他们联系，其中29名参与者被随机分组。在这些人中，有4名参与者在服用任何试验药物之前退出了试验，2名参与者因担心副作用而离开研究。4名参与者的数据缺失，19名完成试验的参与者有完整数据。总体而言，每个研究点每月的平均招募率为1.3名参与者，总体留存率为76%。访谈数据表明，参与者参与试验的体验总体上是积极的。
该可行性研究表明，开展一项使用替代药物治疗CIH的试验是可行的；患者愿意被随机分配到试验中，且留存率较高。
ClinicalTrials.gov，NCT02613494，于2015年11月24日注册。
