ISRCTN17411897已完成3 期
A pragmatic, multi-centre, double-blind, placebo controlled randomised trial to assess the safety, clinical and cost effectiveness of mirtazapine in patients with Alzheimer's Disease (AD) and agitated behaviours
niversity of Sussex0 个研究点目标入组 247 人开始时间: 2016年7月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 247
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34688369/ (added 26/10/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37929672/ (added 06/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years and over
- •2. Clinical diagnosis of probable or possible Alzheimer’s Disease using National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria
- •3. A diagnosis of co-existing agitated behaviours
- •4. Evidence that the agitated behaviours have not responded to management according to the AS/DH algorithm
- •5. If receiving cholinesterase inhibitors or memantine, must be on a stable dose (defined as three months on current dose)
- •6. A Cohen Mansfield Agitation Inventory score of 45 or greater
- •7. Written informed consent to enter and be randomised into the trial or consultee agreement for those without capacity
- •8. Availability of a suitable informant (consenting identifiable family carer or paid carer) to provide information on carer-completed outcome measures and who consents to take part in the trial
排除标准
- •Current exclusion criteria as of 28/01/2019:
- •1. Current treatment with antidepressants (including monoamine oxidase inhibitors (MAOIs)), anticonvulsants, antipsychotics. Patients must have completed treatment with these medications at least two weeks before trial drug administration
- •2. Contraindications to the administration of mirtazapine as per its current SmPCs
- •3. Patients with atrioventricular block, a history of bone marrow depression or history of hepatic porphyrias
- •4. Cases too critical for randomisation (ie where there is a suicide risk or where the patient presents a risk of harm to others)
- •5. Female subjects under the age of 55 of childbearing potential, defined as follows: postmenopausal females who have not had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have not had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
- •Previous exclusion criteria:
- •1. Current treatment with antidepressants (including monoamine oxidase inhibitors (MAOIs)), anticonvulsants, antipsychotics. Patients must have completed treatment with these medications at least two weeks before trial drug administration
- •2. Contraindications to the administration of carbamazepine and mirtazapine as per their current SmPCs
- •3. Patients with atrioventricular block, a history of bone marrow depression or history of hepatic porphyrias
- •4. Cases too critical for randomisation (ie where there is a suicide risk or where the patient presents a risk of harm to others)
- •5. Female subjects under the age of 55 of childbearing potential, defined as follows: postmenopausal females who have not had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have not had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrolment
研究者
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