Optimisation of Antipsychotic Drug Use in Older People
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 and clinical response (symptom reduction and side effect profile) 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.
Non-linear mixed effect modelling will be used to establish the minimum clinically effective dose of amisulpride, optimum dose range and impact of variability and covariates on exposure-response relationships in the 2 patient groups
This information will be used make predictions about amisulpride prescribing of other antipsychotic drugs to the two patient groups.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Rationalisation of Antipsychotic Drug Use in Older People, Using [18F]-Fallypride PET|
- Non-linear mixed effect modelling of pharmacokinetic-pharmacodynamic (PK-PD) parameters in the 2 patient groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To investigate the impact of between subject random variability and covariates (age, gender, renal function and weight) on concentration-occupancy- response relationships in patients with SLP and AD
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
No Intervention: Patients - control group
Control group, no treatment, brain imaging carried out to determine receptor availability in the absence of drug
Experimental: Patients - dose titration
Treatment group, brain imaging carried out pre and post 4-10 weeks treatment
4-10 weeks treatment, 25-100mg daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454453
|Contact: Suzanne J Reeves, MBChB, PhD||020 7848 0002 ext firstname.lastname@example.org|
|Contact: Robert J Howard, MBBS, MD||020 7848 0002 ext email@example.com|
|Institute of Psychiatry, Kings College London||Recruiting|
|London, United Kingdom, SE58AF|
|Principal Investigator: Suzanne J Reeves, MBChB PhD|
|Principal Investigator:||Suzanne J Reeves, MBChB, PhD||Institute of Psychiatry, London|