NCT01454453

Optimisation of Antipsychotic Drug Use in Older People

Rationalisation of Antipsychotic Drug Use in Older People, Using [18F]-Fallypride PET

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Institute of Psychiatry, London · Academic / Other
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Not accepted

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 in older people with dementia and schizophrenia-like illness, and translate these findings into direct patient benefit. The aim of the study is to investigate and compare the relationship between the action of amisulpride at brain sites during the first 10 weeks of amisulpride treatment in two patient groups - Alzheimer's disease and schizophrenia-like illness. Imaging data will be combined with data on drug dosage, levels of drug in the bloodstream and clinical response (symptom reduction and motor side effects) during dose titration.Dose-response modelling will be carried out in both groups to establish the minimum clinically effective dose of amisulpride, optimum dose range and impact of variability and covariates on exposure-response relationships

Conditions

• Alzheimer's Disease
• Schizophrenia

Interventions

Type	Name	Description
DRUG	Patients- dose titration	dose titration (patients) - 4-10 weeks

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-10-19
• Last updated: 2017-04-19

Locations

1 site across 1 country: United Kingdom