Optimisation of Antipsychotic Drug Use in Older People

NCT01454453 | Terminated Phase 4

• 1 other identifier: 2167SR
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer's Disease; Schizophrenia

Keywords

amisulpride; receptor occupancy; antipsychotic sensitivity

Outcome Measures

Primary Outcomes (1)

• dose titration

  receptor occupancy compared across 2 patient groups following dose-titration

  12 weeks

Other Outcomes (1)

• modelling of dose-response relationships

  12 weeks

Study Arms (1)

Patients - dose titration

EXPERIMENTAL

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

Drug: Patients- dose titration

Interventions

Patients- dose titration DRUG

dose titration (patients) - 4-10 weeks

Patients - dose titration

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Psychiatry, London: lead

Study Sites (1)

Institute of Psychiatry, Kings College London

London, SE58AF, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease; Schizophrenia

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Suzanne J Reeves, MBChB, PhD

  Institute of Psychiatry, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 19, 2011
• Study Start: May 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)