Optimisation of Antipsychotic Drug Use in Older People

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01454453
• Other study ID #: 2167SR
• Status: Terminated
• Phase: Phase 4
• First received: October 12, 2011
• Last updated: April 18, 2017
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: April 2017
• Source: Institute of Psychiatry, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Schizophrenia

Intervention

Drug:
• Patients- dose titration
dose titration (patients) - 4-10 weeks

Locations

Country	Name	City	State
United Kingdom	Institute of Psychiatry, Kings College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Psychiatry, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	modelling of dose-response relationships	dose-response modelling	12 weeks
Primary	dose titration	receptor occupancy compared across 2 patient groups following dose-titration	12 weeks