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 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.
|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|
- Dopamine D2/3 receptor occupancy at steady state (4 days) treatment with 50mg amisulpride [ Time Frame: Day 5 ] [ Designated as safety issue: No ](i) To investigate the relationship between plasma levels and regional D2/3 receptor occupancy following steady state (4 days) treatment with a fixed dose (50mg) of amisulpride within 3 groups: Healthy controls (HC), AD and SLP (20 in each group).
- Dopamine D2/3 receptor occupancy during 4-10 weeks treatment with 50-200mg amisulpride [ Time Frame: 4-10 weeks ] [ Designated as safety issue: No ](ii) To investigate the relationship between plasma kinetics, regional D2/3 receptor occupancy and therapeutic and adverse effect profile in patients with SLP and AD (20 in each group) during 4-10 weeks treatment with amisulpride (50-200mg daily).
- neuropsychological test performance [ Time Frame: 4-10 weeks ] [ Designated as safety issue: No ]Changes in neuropsychological test performance after 4-10 weeks amisulpride treatment
|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)|
Experimental: Healthy participants
4 days (steady state) treatment
4 days treatment 50 mg daily
Experimental: Patients - steady state treatment
Amisulpride treatment group, brain imaging carried out pre and post 4 days treatment, does titration continues for up to 10 weeks
4 days treatment, 50mg daily
No Intervention: Patients - control group
Control group, no treatment
Experimental: Patients - dose titration
Treatment group, brain imaging carried out pre and post 4-10 weeks treatment
4-10 weeks treatment, 50-200mg 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|