Optimisation of Antipsychotic Drug Use in Older People

Phase 4

Terminated

• Conditions: Schizophrenia; Alzheimer's Disease
• Interventions: Drug: Patients- dose titration

• Registration Number: NCT01454453
• Lead Sponsor: Institute of Psychiatry, London

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-19
• Study Start: 2012-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients - dose titration	Patients- dose titration	Amisulpride 50-200mg, 4-12 weeks, with brain imaging

Primary Outcome Measures

Name	Time	Method
dose titration	12 weeks	receptor occupancy compared across 2 patient groups following dose-titration

Trial Locations

Locations (1)

Institute of Psychiatry, Kings College London; 🇬🇧 London, United Kingdom