Clinical trial NCT01454453: Optimisation of Antipsychotic Drug Use in Older People
Official title: Rationalisation of Antipsychotic Drug Use in Older People, Using [18F]-Fallypride PET
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alzheimer's Disease
Schizophrenia
Keywords: amisulpride
receptor occupancy
antipsychotic sensitivity
Lead sponsor: Institute of Psychiatry, London
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility 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

* Prescribed psychotropic medication
* unable to give informed consent

Alzheimer's

• Prescribed psychotropic medication

Primary outcomes:
measure: dose titration
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: modelling of dose-response relationships
timeFrame: 12 weeks
Locations:
city: London
country: United Kingdom
facility: Institute of Psychiatry, Kings College London
Study officials:
affiliation: Institute of Psychiatry, London
name: Suzanne J Reeves, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References: