Optimisation of Antipsychotic Drug Use in Older People

Institute of Psychiatry, London

Status and phase

Terminated

Phase 4

Conditions

Alzheimer's Disease

Schizophrenia

Treatments

Drug: Patients- dose titration

Study type

Interventional

Funder types

Other

Identifiers

NCT01454453

2167SR

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

All

Ages

60 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Treatment and Control (antipsychotic free) Group

Schizophrenia

meet diagnostic criteria for schizophrenia-like illness
aged between 60 and 95 years of age
score <6 on the Geriatric depression scale

Alzheimer's

meet diagnostic criteria for AD
score <=4 on the Modified Hachinski Ischaemia Scale
score < 8 on a modified version of the UPDRS
aged between 60 and 95 years of age
score <6 on the Geriatric depression scale

Exclusion Criteria

Treatment Group

Schizophrenia

current or past history of addiction, traumatic brain injury or epilepsy
prescribed any drug that interferes with brain dopamine in past 2 weeks (6 weeks if depot antipsychotic medication).
medical conditions that might affect Ability to tolerate a brain scan
unable to give informed consent

Alzheimer's

current or past history of psychiatric illness, traumatic brain injury or epilepsy
prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks if depot antipsychotic medication).
medical conditions that might affect a person's ability to tolerate a brain scan

Control (antipsychotic free) Group

Schizophrenia