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Optimisation of Antipsychotic Drug Use in Older People

Primary Purpose

Alzheimer's Disease, Schizophrenia

Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Patients- dose titration
Sponsored by
Institute of Psychiatry, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring amisulpride, receptor occupancy, antipsychotic sensitivity

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of Psychiatry, Kings College London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients - dose titration

Arm Description

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

Outcomes

Primary Outcome Measures

dose titration
receptor occupancy compared across 2 patient groups following dose-titration

Secondary Outcome Measures

Full Information

First Posted
October 12, 2011
Last Updated
April 18, 2017
Sponsor
Institute of Psychiatry, London
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1. Study Identification

Unique Protocol Identification Number
NCT01454453
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit people with very late onset schizophrenia like psychosis
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Psychiatry, London

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Schizophrenia
Keywords
amisulpride, receptor occupancy, antipsychotic sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients - dose titration
Arm Type
Experimental
Arm Description
Amisulpride 50-200mg, 4-12 weeks, with brain imaging
Intervention Type
Drug
Intervention Name(s)
Patients- dose titration
Intervention Description
dose titration (patients) - 4-10 weeks
Primary Outcome Measure Information:
Title
dose titration
Description
receptor occupancy compared across 2 patient groups following dose-titration
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
modelling of dose-response relationships
Description
dose-response modelling
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne J Reeves, MBChB, PhD
Organizational Affiliation
Institute of Psychiatry, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry, Kings College London
City
London
ZIP/Postal Code
SE58AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimisation of Antipsychotic Drug Use in Older People

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