Optimisation of Antipsychotic Drug Use in Older People

April 18, 2017 updated by: Suzanne Reeves, Institute of Psychiatry, London

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE58AF
        • Institute of Psychiatry, Kings College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose titration
Time Frame: 12 weeks
receptor occupancy compared across 2 patient groups following dose-titration
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
modelling of dose-response relationships
Time Frame: 12 weeks
dose-response modelling
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Psychiatry, London

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (ESTIMATE)

October 19, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2167SR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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