EUCTR2011-005218-13-GB进行中（未招募）1 期
Rationalisation of antipsychotic drug use in older people, using [18F]-Fallypride PET - Optimisation of amisulpride prescribing in older people
Kings College London0 个研究点目标入组 40 人开始时间: 2012年2月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy participants will be included if they
- •(i)are aged between 60 and 95 years of age
- •(ii)are male or female
- •(iii)score <6 on the Geriatric depression scale (GDS)
- •(iv)score >26/30 on the Mini Mental State Examination
- •Patients with SLP will be included if they
- •(i)meet diagnostic criteria for SLP (a non-affective, non-organic psychosis)
- •(ii)are aged between 60 and 95 years of age
- •(iii)are male or female
- •(iv)score <6 on the Geriatric Depression Scale (GDS)
- •(v)have been deemed eligible to receive amisulpride treatment by the prescribing clinician, but have not yet commenced treatment l
- •Patients with AD will be included if they
- •(i)meet National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders (NINCDS/ADRDA) criteria for AD
- •(ii)score <=4 on the Modified Hachinski Ischaemia Scale (MHIS)
- •(iii)score < 8 on a modified version of the Unified Parkinson’s Disease Rating scale (UPDRS) motor component
- •(iv)score <6 on the Geriatric Depression Scale
- •(v)are aged between 60 and 95 years of age
- •(vi)are male or female
- •(vii)have been deemed eligible to receive amisulpride for the treatment of behavioural or psychotic symptoms by the prescribing clinician, but have not yet commenced treatment l
- •l this does not apply to the control group (group 4), who may be on or off psychotropic medication, provided there has been no change in dose over the previous 2 weeks (6 weeks if depot)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •Healthy participants will be excluded for the following reasons:
- •(i)current or past psychiatric illness (such as schizophrenia), addiction (drug or alcohol), traumatic brain injury or epilepsy
- •(ii)prescribed psychotropic or other oral medication that might interfere with brain dopamine function in the past 2 weeks (6 weeks for depot medication).
- •(iii)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
- •(iv)unable to give informed consent
- •Patients with SLP will be excluded for the following reasons
- •(i)past history of addiction (drug or alcohol), traumatic brain injury or epilepsy
- •(ii)prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks for depot medication)*
- •(iii)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
- •(iv)unable to give informed consent
- •Patients with AD will be excluded for the following reasons
- •(i)past history of schizophrenia (before the age of 60 years), addiction (drug or alcohol), traumatic brain injury or epilepsy
- •(ii)prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks for depot medication)*
- •(iii)overt parkinsonian (facial masking, action tremor, resting tremor rigidity, bradykinesia) features (scores >7 on the modified UPDRS) (Ballard 1997) or other features suggestive of a Lewy Body Dementia including fluctuating conscious level, frequent falls, or visual hallucinations as a predominant feature.
- •(iv)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
- •l patients with AD who are unable to give informed consent because of illness severity will not be excluded, but will require the carer to provide assent as personal legal representative.
- •Although MRI is required to optimise analysis of PET data in groups 1-3, alternative methods are being explored (for example creating a template from existing participants to map PET data on to), hence participants in whom an MRI scan is contraindicated will not necessarily be excluded.
- •*For group 4, participants will only be excluded if there has been a change in psychotropic prescribing (2 weeks for oral medication, 6 weeks for depot)
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