Optimisation of amisulpride prescribing in older people

• Research type

  Research Study

• Full title

  Rationalisation of antipsychotic drug use in older people, using [18F]-Fallypride PET

• IRAS ID

  72296

• Contact name

  Suzanne Reeves

• Sponsor organisation

  Kings College London

• Eudract number

  2011-005218-13

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Drugs such as amisulpride, known as ??antipsychotic?? drugs, are used to treat troublesome and distressing symptoms in older people. Although these drugs can be beneficial, they are associated with side effects, particularly in patients with dementia and schizophrenia-like illness. There is an urgent clinical need to understand why this is the case, to guide treatment strategies. This study aims to utilise brain imaging techniques that measure the action of antipsychotic drugs in the brain to explore the causes of this susceptibility is older people with dementia and schizophrenia, and translate these findings into direct patient benefit. The first aim is to establish whether people with dementia have an increased risk of side effects because more of the drug gains access to the brain. This will be tested using a low (starter) dose of the commonly prescribed drug amisulpride and comparing people with dementia with two other groups - healthy participants and people with schizophrenia-like illness. The second aim is to investigate and compare the relationship between the action of amisulpride at brain sites and clinical response (symptom reduction and side effect profile) during the first 10 weeks of amisulpride treatment in the two patient groups. Patients involved in the brain imaging studies described above will also have information on drug dosage, levels of drug in the bloodstream and clinical response collected as drug dose is increased over a 10 week period. The information gathered from these studies will help us to establish the minimum clinically effective dose and optimum dose range of amisulpride required to treat symptoms without side effects. An understanding of how the action of drugs like amisulpride at brain sites relates to clinical response will also help us to make predictions about the prescribing of other antipsychotic drugs to the two patient groups.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  11/SC/0486

• Date of REC Opinion

  10 Feb 2012

• REC opinion

  Further Information Favourable Opinion