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Optimisation of Antipsychotic Drug Use in Older People

This study has been terminated.
(Failure to recruit people with very late onset schizophrenia like psychosis)
Sponsor:
Information provided by (Responsible Party):
Suzanne Reeves, Institute of Psychiatry, London
ClinicalTrials.gov Identifier:
NCT01454453
First received: October 12, 2011
Last updated: April 18, 2017
Last verified: April 2017
  Purpose

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 Intervention Phase
Alzheimer's Disease Schizophrenia Drug: Patients- dose titration Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Suzanne Reeves, Institute of Psychiatry, London:

Primary Outcome Measures:
  • dose titration [ Time Frame: 12 weeks ]
    receptor occupancy compared across 2 patient groups following dose-titration


Other Outcome Measures:
  • modelling of dose-response relationships [ Time Frame: 12 weeks ]
    dose-response modelling


Enrollment: 64
Study Start Date: May 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients - dose titration
Amisulpride 50-200mg, 4-12 weeks, with brain imaging
Drug: Patients- dose titration
dose titration (patients) - 4-10 weeks

  Eligibility

Ages Eligible for Study:   60 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454453

Locations
United Kingdom
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
  More Information

Responsible Party: Suzanne Reeves, Clinician Scientist, Institute of Psychiatry, London
ClinicalTrials.gov Identifier: NCT01454453     History of Changes
Other Study ID Numbers: 2167SR
Study First Received: October 12, 2011
Last Updated: April 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not available

Keywords provided by Suzanne Reeves, Institute of Psychiatry, London:
amisulpride
receptor occupancy
antipsychotic sensitivity

Additional relevant MeSH terms:
Schizophrenia
Alzheimer Disease
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 19, 2017