Optimisation of amisulpride prescribing in older people

Phase 1

• Conditions: Alzheimer's Disease and schizophrenia likeillness; MedDRA version: 17.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; MedDRA version: 17.0Level: LLTClassification code 10032928Term: Other specified types of schizophreniaSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2011-005218-13-GB
• Lead Sponsor: Kings College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-28
• Study Completion: 2016-02-04
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Healthy participants will be included if they
(i)are aged between 60 and 95 years of age
(ii)are male or female
(iii)score <6 on the Geriatric depression scale (GDS)
(iv)score >26/30 on the Mini Mental State Examination

Patients with SLP will be included if they
(i)meet diagnostic criteria for SLP (a non-affective, non-organic psychosis)
(ii)are aged between 60 and 95 years of age
(iii)are male or female
(iv)score <6 on the Geriatric Depression Scale (GDS)
(v)have been deemed eligible to receive amisulpride treatment by the prescribing clinician, but have not yet commenced treatment l

Patients with AD will be included if they
(i)meet National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders (NINCDS/ADRDA) criteria for AD
(ii)score <=4 on the Modified Hachinski Ischaemia Scale (MHIS)
(iii)score < 8 on a modified version of the Unified Parkinson’s Disease Rating scale (UPDRS) motor component
(iv)score <6 on the Geriatric Depression Scale
(v)are aged between 60 and 95 years of age
(vi)are male or female
(vii)have been deemed eligible to receive amisulpride for the treatment of behavioural or psychotic symptoms by the prescribing clinician, but have not yet commenced treatment l

l this does not apply to the control group (group 4), who may be on or off psychotropic medication, provided there has been no change in dose over the previous 2 weeks (6 weeks if depot)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

Healthy participants will be excluded for the following reasons:
(i)current or past psychiatric illness (such as schizophrenia), addiction (drug or alcohol), traumatic brain injury or epilepsy
(ii)prescribed psychotropic or other oral medication that might interfere with brain dopamine function in the past 2 weeks (6 weeks for depot medication).
(iii)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
(iv)unable to give informed consent

Patients with SLP will be excluded for the following reasons
(i)past history of addiction (drug or alcohol), traumatic brain injury or epilepsy
(ii)prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks for depot medication)*
(iii)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
(iv)unable to give informed consent

Patients with AD will be excluded for the following reasons
(i)past history of schizophrenia (before the age of 60 years), addiction (drug or alcohol), traumatic brain injury or epilepsy
(ii)prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks for depot medication)*
(iii)overt parkinsonian (facial masking, action tremor, resting tremor rigidity, bradykinesia) features (scores >7 on the modified UPDRS) (Ballard 1997) or other features suggestive of a Lewy Body Dementia including fluctuating conscious level, frequent falls, or visual hallucinations as a predominant feature.
(iv)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
l patients with AD who are unable to give informed consent because of illness severity will not be excluded, but will require the carer to provide assent as personal legal representative.

Although MRI is required to optimise analysis of PET data in groups 1-3, alternative methods are being explored (for example creating a template from existing participants to map PET data on to), hence participants in whom an MRI scan is contraindicated will not necessarily be excluded.

*For group 4, participants will only be excluded if there has been a change in psychotropic prescribing (2 weeks for oral medication, 6 weeks for depot)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified