Optimisation of Antipsychotic Drug Use in Older People | NCT01454453

Studies
Optimisation of Antipsychotic Drug Use in Older People

NCT01454453

Sponsor

Institute of Psychiatry, London

Status

Terminated

Last Update Posted

Apr 19, 2017Actual

Enrollment

64Actual

Phase

Phase 4

Conditions

Alzheimer's Disease
Schizophrenia

Interventions

Patients- dose titration

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failure to recruit people with very late onset schizophrenia like psychosis

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Oct 12, 2011

First Submission Date that Met QC Criteria

Oct 17, 2011

First Posted Date

Oct 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2017

Last Update Posted Date

Apr 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Label	Type	Description	Intervention Names
Patients - dose titration	Experimental	Amisulpride 50-200mg, 4-12 weeks, with brain imaging	Drug: Patients- dose titration

Name	Type	Description	Arm Group Labels	Other Names
Patients- dose titration	Drug	dose titration (patients) - 4-10 weeks	Patients - dose titration

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

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000544	Alzheimer Disease
D012559	Schizophrenia