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Optimisation of Antipsychotic Drug Use in Older People

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Institute of Psychiatry, London
Sponsor:
Information provided by (Responsible Party):
Suzanne Reeves, Institute of Psychiatry, London
ClinicalTrials.gov Identifier:
NCT01454453
First received: October 12, 2011
Last updated: March 24, 2015
Last verified: March 2015
  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 and clinical response (symptom reduction and side effect profile) 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.

Non-linear mixed effect modelling will be used to establish the minimum clinically effective dose of amisulpride, optimum dose range and impact of variability and covariates on exposure-response relationships in the 2 patient groups

This information will be used make predictions about amisulpride prescribing of other antipsychotic drugs to the two patient groups.


Condition Intervention Phase
Alzheimer's Disease
Schizophrenia
Drug: amisulpride
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 Institute of Psychiatry, London:

Primary Outcome Measures:
  • Non-linear mixed effect modelling of pharmacokinetic-pharmacodynamic (PK-PD) parameters in the 2 patient groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To investigate the impact of between subject random variability and covariates (age, gender, renal function and weight) on concentration-occupancy- response relationships in patients with SLP and AD


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Patients - control group
Control group, no treatment, brain imaging carried out to determine receptor availability in the absence of drug
Experimental: Patients - dose titration
Treatment group, brain imaging carried out pre and post 4-10 weeks treatment
Drug: amisulpride
4-10 weeks treatment, 25-100mg daily

  Eligibility

Ages Eligible for Study:   60 Years to 95 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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

Contacts
Contact: Suzanne J Reeves, MBChB, PhD 020 7848 0002 ext 0548 suzanne.j.reeves@kcl.ac.uk
Contact: Robert J Howard, MBBS, MD 020 7848 0002 ext 0545 robert.j.howard@kcl.ac.uk

Locations
United Kingdom
Institute of Psychiatry, Kings College London Recruiting
London, United Kingdom, SE58AF
Principal Investigator: Suzanne J Reeves, MBChB PhD         
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: March 24, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by 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
Sultopride
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016