Optimisation of Antipsychotic Drug Use in Older People

Sponsor

Institute of Psychiatry, London (Other)

Overall Status

Terminated

CT.gov ID

NCT01454453

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Schizophrenia	Drug: Patients- dose titration	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients - dose titration Amisulpride 50-200mg, 4-12 weeks, with brain imaging	Drug: Patients- dose titration dose titration (patients) - 4-10 weeks

Arm

Intervention/Treatment

Experimental: Patients - dose titration

Amisulpride 50-200mg, 4-12 weeks, with brain imaging

Drug: Patients- dose titration

dose titration (patients) - 4-10 weeks

Outcome Measures

Primary Outcome Measures

dose titration [12 weeks]
receptor occupancy compared across 2 patient groups following dose-titration

Other Outcome Measures

modelling of dose-response relationships [12 weeks]
dose-response modelling

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Psychiatry, Kings College London	London		United Kingdom	SE58AF

Sponsors and Collaborators

Institute of Psychiatry, London

Investigators

Principal Investigator: Suzanne J Reeves, MBChB, PhD, Institute of Psychiatry, London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suzanne Reeves, Clinician Scientist, Institute of Psychiatry, London

ClinicalTrials.gov Identifier:

NCT01454453

Other Study ID Numbers:

2167SR

First Posted:

Oct 19, 2011

Last Update Posted:

Apr 19, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Suzanne Reeves, Clinician Scientist, Institute of Psychiatry, London

amisulpride

receptor occupancy

antipsychotic sensitivity

Additional relevant MeSH terms:

Alzheimer Disease

Schizophrenia

Study Results

No Results Posted as of Apr 19, 2017