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BPSD - Devon Partnership NHS Trust

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Prescribing Guideline<br />

Pharmacological Management of<br />

Severe Behavioural & Psychological<br />

Symptoms of Dementia (<strong>BPSD</strong>)<br />

PG14<br />

Document Control<br />

Version Date Issued Author Name / Job Title / Email<br />

1.0 March 2011 Amanda Gulbranson Christopher Sullivan<br />

Clinical Effectiveness Lead Lead Clinical Pharmacist<br />

Amanda.gulbranson@nhs.net Christopher.sullivan@nhs.net<br />

2.0 September 2013 Amanda Gulbranson Richard Mccollum<br />

Clinical Effectiveness Lead Consultant Psychiatrist<br />

Amanda.gulbranson@nhs.net richard.mccollum@nhs.net<br />

Target Audience/staff groups Clinical staff responsible for the prescribing of treatment for Behavioural and<br />

Psychological Symptoms of Dementia.<br />

Ratifying group<br />

Drug and Therapeutics Committee<br />

Date Ratified 4 th September 2013<br />

Implementation date October 2013<br />

Review date September 2015<br />

Document History<br />

Version Start End date Author History<br />

date<br />

0.1 Nov 2010 AG First draft of new Prescribing Guideline<br />

0.2 Dec 10 CS Multiple changes post MHPF meeting Dec 10 (CS)<br />

0.3 Feb 2011 AG/CS Changes following discussion with Denise Cope & Steven Pearson<br />

( Consultant OPMH Psychiatrist Dorset & <strong>Devon</strong> respectively)<br />

0.4 Feb 2011 01.03.11 AG/CS Minor corrects/typos and abbreviations. Presented to Mental<br />

Health Prescribing Forum for comment<br />

0.5 Feb 2011 07.03.11 CS Changes made post OPMH meeting<br />

1.0 22.03.11 KS Document signed off.<br />

1.1 Mar13 AG Table of treatment strategies removed and included in Appendix 1<br />

Reference to ‘FACE’ form removed<br />

Decision aid for specialist treatment updated<br />

Link to standard GP letter added<br />

2.0 Oct13 KS Document ratified at DTC and signed off.<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 1 of 10


Pharmacological Management of Severe Behavioural & Psychological<br />

Symptoms of Dementia (<strong>BPSD</strong>)<br />

The aim of these guidelines is to promote evidence based, cost effective prescribing and<br />

support adherence to:<br />

o NICE Clinical Guideline CG42: Dementia (Nov 2006)<br />

o The use of antipsychotic medication for people with dementia: Time for action.<br />

(Banerjee 2009: Department of Health)<br />

o NICE Quality Standard QS01: Dementia (June 2010)<br />

o Alzheimer’s Society (2011): Optimising treatment and care for people with<br />

behavioural and psychological symptoms of dementia- A best practice guide for<br />

health and social care professionals<br />

The guidelines are NOT intended to replace prescribing information contained in the BNF or<br />

Summary of Product Characteristics.<br />

Treatment choice and duration<br />

Behavioural and psychological symptoms occur in about 90% of individuals with dementia,<br />

(frequency increases with severity of dementia), causing considerable distress and/or risk of harm<br />

to the individual, increasing distress to the family/carer and potentially interfering with/preventing<br />

the provision of required care.<br />

The presenting neuropsychiatric symptoms include psychosis, agitation, aggression, mood<br />

disorder and wandering and are collectively referred to as ‘behavioural and psychological<br />

symptoms of dementia’ (<strong>BPSD</strong>).<br />

For people with a diagnosis of dementia, behaviours that challenge are best ‘managed’ by good<br />

nursing care, the correct environment and use of ‘ABC’ (antecedents, behaviours and<br />

consequences) to try and identify causes and possible triggers for the presenting behaviour (e.g.<br />

hunger, pain).<br />

Non-pharmacological approaches must always be considered first<br />

(but are beyond the scope of, and not covered in, this guideline)<br />

Pharmacological treatment is not a substitute for non-pharmacological approaches and these<br />

techniques must always be used concurrently.<br />

Where non-pharmacological interventions have failed or are inappropriate, other possible causes<br />

(i.e. physical illness) should be eliminated prior to considering an individual trial of medication for<br />

the management of <strong>BPSD</strong> using the Pharmacological Treatment Algorithm below.<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 2 of 10


No further intervention needed at this time. Continue to provide care for individual in accordance<br />

with current care-plan<br />

Individual presents with behaviours that challenge (e.g. agitation, wandering, aggression, tearfulness,<br />

sexual disinhibition shouting, hallucinations, delirium)<br />

Identify and document target symptoms, severity and level of distress caused to individual<br />

(Use suitable assessment tool i.e. Cohen–Mansfield Scale or Neuropsychiatric Inventory )<br />

Could presenting<br />

symptoms be a<br />

result of underlying<br />

physical cause<br />

(including pain)<br />

YES<br />

Assess,<br />

diagnose and<br />

provide<br />

appropriate<br />

treatment<br />

Symptoms<br />

resolved<br />

NO<br />

YES<br />

NO<br />

Could<br />

presenting<br />

symptoms be sideeffects<br />

of<br />

concurrently<br />

prescribed<br />

medication<br />

YES<br />

Complete a<br />

medication<br />

review and<br />

rationalise<br />

treatment<br />

Symptoms<br />

resolved<br />

YES<br />

NO<br />

NO<br />

Could presenting<br />

symptoms be<br />

caused by<br />

underlying<br />

depressive illness<br />

and/ or anxiety<br />

disorder<br />

YES<br />

Assess, diagnose<br />

and provide<br />

appropriate<br />

treatment (refer to<br />

local prescribing<br />

guidelines)<br />

Symptoms<br />

resolved<br />

YES<br />

NO<br />

NO<br />

Consider and implement<br />

appropriate nonpharmacological<br />

interventions<br />

(e.g. environmental changes,<br />

psychological therapies,<br />

multisensory stimulation,<br />

massage, aromatherapy)<br />

Symptoms<br />

resolved<br />

YES<br />

Consider, discuss and provide<br />

appropriate pharmacotherapy<br />

in accordance with this<br />

prescribing guidance (PG14)<br />

NO<br />

Symptoms<br />

resolved<br />

NO<br />

YES<br />

Review prescribed<br />

medication regularly. After a<br />

period of 3 months, aim to<br />

reduce and stop medication<br />

when presenting behaviour<br />

has settled.<br />

Advise GP of plan to reduce<br />

and stop medication if still<br />

prescribed medication (after<br />

a trial of reduction) on<br />

discharge from in-patient<br />

unit or community team<br />

Where a medication has been ineffective, always stop it before introducing a subsequent treatment<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 3 of 10


Pharmacological Management:<br />

The expected benefits must outweigh the potential risks/side effects of medication for each individual.<br />

Pharmacological management of severe <strong>BPSD</strong> (agitation and aggression in particular) should only be<br />

considered if behaviours cause severe distress to the individual and/or there is immediate risk of<br />

harm to other patients or carers. Remember- wandering behaviour does NOT respond to medication.<br />

Medication prescribed for the management of <strong>BPSD</strong> should be considered as an individual<br />

therapeutic trail, with the choice of medication based upon an individual risk-benefit analysis.<br />

Always “START LOW AND GO VERY SLOW”.<br />

Treatment choice and duration:<br />

Once a decision has been reached to start medication for the management of <strong>BPSD</strong> the first choice<br />

of treatment considered should be;<br />

Risperidone<br />

Initial dose of 250micrograms twice a day recommended.<br />

This may be increased according to response in steps of 250micrograms twice a day on alternate<br />

days. Usual dose 500micrograms twice a day (but doses up to 1mg twice a day may be beneficial<br />

for some individuals).<br />

Risperidone is the only medication with UK Marketing authorisation for this indication, licensed for<br />

“the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to<br />

severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is<br />

a risk of harm to self or others”.<br />

Antipsychotic drugs are known to be harmful and can have severe side-effects and it is vital that<br />

any person prescribed risperidone (or other antipsychotic) is monitored for side-effects and<br />

progression of symptoms.<br />

Exercise caution if risperidone is prescribed together with furosemide (higher incident of mortality<br />

observed although mechanism unclear). The risks and benefits of combining risperidone with<br />

furosemide or other potent diuretics must be considered prior to use. Refer to Risperidone SPC for<br />

more information.<br />

The most important adverse effects associated with antipsychotics are parkinsonism, falls,<br />

dehydration, chest infections, ankle oedema, deep vein thrombosis/pulmonary embolism, cardiac<br />

arrhythmia and stroke (highest risk in first four weeks of treatment). Antipsychotics are also<br />

associated with increased mortality in the long term (often related to pneumonia and thromboembolic<br />

events) which can be caused by over-sedation and dehydration.<br />

Complete a cardiac risk assessment prior to initiating treatment.<br />

Weekly monitoring of sedation, fluid intake and early indicators of chest infection is strongly<br />

recommended.<br />

Caution: antipsychotics should not be used in someone with Lewy Body Dementia (LBD)<br />

Where<br />

without<br />

risperidone<br />

specialist<br />

is contraindicated<br />

advice.<br />

or where no clinical benefit is achieved and/or the individual<br />

experiences intolerable side effects, it may be appropriate to consider alternative pharmacological<br />

treatment options (to be initiated by or on the recommendation of a specialist).<br />

The available evidence base is insufficient to support specific recommendations on preferred<br />

choices of medication or the order in which different medicines/different classes of medication<br />

should be prescribed.<br />

Refer to the Decision aid for specialist treatment strategies-Severe <strong>BPSD</strong> (Appendix 1)<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 4 of 10


Initiation of medication (by, or on the recommendation from, a specialist):<br />

Identify, quantify & document target symptoms including severity and level of distress caused<br />

to the individual (and family/carers where appropriate) and set realistic treatment goals.<br />

Suitable assessment tools include Adapted Cohen –Mansfield Agitation Inventory (Adapted<br />

CMAI) or Neuropsychiatric Inventory (NPI).<br />

The Adapted Cohen–Mansfield Agitation Inventory is available here<br />

Document which non-pharmacological interventions have been used and/or offered to the<br />

individual (as appropriate) and level of effectiveness.<br />

Complete baseline physical monitoring, appropriate to the individual drug prescribed.<br />

Complete baseline assessment of cognition.<br />

Clearly record rationale for treatment and choice of medication in the clinical notes, including<br />

agreed start date and initial treatment review date (& person responsible for completion).<br />

It is recognised that when medication is prescribed for the management of <strong>BPSD</strong> it will<br />

generally arise from a ‘best interest decision’. The prescriber must ensure that a formal record<br />

of capacity assessment is completed (using RiO capacity assessment form) and a summary<br />

of multi-professional team discussion and rationale for treatment clearly documents in the<br />

notes (including information provided to family and/or carers where applicable).<br />

Communication of information to family/carers:<br />

The prescriber must discuss the possible treatment options with the individual and/or<br />

family/carers, including the anticipated benefits and potential risks of treatment (in particular,<br />

cerebrovascular risk factors should be assessed and the possible increased risk of<br />

stroke/transient ischaemic attack and possible adverse effects on cognition discussed).<br />

Provide information in an appropriate format to support discussion about expected benefits<br />

and possible risks of treatment (see user-friendly resources).<br />

A summary of the discussion (and note of any additional information provided) must be clearly<br />

documented in the clinical notes.<br />

During treatment:<br />

Regularly monitor response to treatment/changes in target symptoms & document in notes<br />

Assess cognition at regular intervals, and document any required action(s)/treatment plan to<br />

address any deterioration in cognition in the notes<br />

Monitor for emergence of side effects associated with mediation. Discuss with individual<br />

and/or carer and review treatment if side effects intolerable or severe. (NB people with DLB<br />

have increased sensitivity to antipsychotic side effects, including acute & severe physical<br />

deterioration- monitor carefully).<br />

Ensure on-going physical monitoring is carried out appropriate to the medication prescribed.<br />

Document subsequent treatment review dates (& person responsible) in the clinical notes at<br />

each clinical review. Treatment should be time-limited and regularly reviewed.<br />

Reviewing and stopping treatment:<br />

Treatment should be reviewed at 6 and/or twelve weeks (with more frequent review<br />

considered according to clinical need).<br />

Following review, unless there is severe risk or extreme distress, the recommended default<br />

management is to discontinue antipsychotic medication.<br />

When stopping medication, if the daily dose of risperidone is 500micrograms or less<br />

immediate discontinuation is recommended. For higher doses a gradual reduction is<br />

preferable to abrupt withdrawal, i.e. reduce dose by 50% of total daily dose every 1-2 weeks<br />

until dose of 500micrograms or less/day reached, then stop minimum dose after 1-2 weeks.<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 5 of 10


Acute management in an emergency situation:<br />

For individuals, receiving treatment on an in-patient ward only, where physically violent and<br />

aggressive behaviour has or may imminently result in harm to the individual and/or others, it may be<br />

appropriate to consider ‘rapid tranquillisation’ where repeated attempts at non-pharmacological<br />

interventions and oral medication has failed to produce any benefit (or has been refused). Refer to<br />

the <strong>Trust</strong> Policy for Rapid Tranquillisation (C36) and Clinical Protocol (CP11). This protocol states<br />

antipsychotic medication is not suitable for use in rapid tranquilisation in this population.<br />

Communication of information on transfer of care:<br />

Following a treatment review, it may be appropriate for the medication to be continued for an<br />

agreed period of time following discharge from an in-patient unit, or after review by a specialist<br />

in a community team.<br />

Where it is appropriate for treatment to be continued in primary care, the <strong>Trust</strong> prescriber<br />

(Consultant or Associate specialist) will:<br />

o Contact individual’s GP to request that they accept on-going responsibility for<br />

prescribing<br />

o Where prescribing is to be continued by GP- provide them with a clear treatment plan<br />

to cover the reduction and discontinuation of medication for <strong>BPSD</strong> and who to<br />

contact if they need to seek further advice on the clinical management of the<br />

individual (i.e. original symptoms re-emerge on discontinuation of treatment).<br />

o Include a summary of the information documented in the clinical notes regarding<br />

target symptoms and choice of medication and rationale for treatment.<br />

A standard letter template for communicating prescribing information to GPs is available here<br />

User-friendly resources<br />

Patient decision aid (intended to assist healthcare professionals in consultations with people with<br />

dementia and their family/carers) when treatment with antipsychotic drugs is being considered for<br />

<strong>BPSD</strong>: http://www.npci.org.uk/therapeutics/cns/dementia/resources/pda_dementia_antipsychotics.pdf<br />

Leaflets for patients/family/carers on dementia can be found on the Alzheimer’s Society website:<br />

www.alzheimers.org.uk/Facts_about_dementia/factsheets.htm)<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 6 of 10


Appendix 1<br />

Decision aid for specialist treatment strategies: Severe <strong>BPSD</strong><br />

There is a lack of high quality clinical trial evidence to support the effectiveness of medication for <strong>BPSD</strong><br />

(with evidence base generally based on Alzheimer’s dementia rather than vascular/stroke related, frontotemporal<br />

lobe, mixed or DLB), however increasingly there is information which questions their safety. The<br />

table below is designed to provide you with a summary the available evidence for drugs used for the<br />

management of <strong>BPSD</strong> (specific to aggression, agitation and/or psychosis), along with a summary of<br />

possible side effects and precautions required.<br />

ANTIPSYCHOTICS<br />

Evidence of efficacy in <strong>BPSD</strong>, though limited, is greatest for risperidone and olanzapine, however, clinical<br />

efficacy is at best only modest and this must be balanced against elevated risk of cerebrovascular adverse<br />

events, mortality, upper respiratory infections, oedema, extrapyramidal symptoms and an increase in overall<br />

mortality rate which applies to ALL ANTIPSYCHOTICS (first and second generation) and not just<br />

risperidone and olanzapine as originally reported in the Committee of Safety of Medicines alert (2004).<br />

Summary of risks and benefits for treating1000 people with dementia for <strong>BPSD</strong> over a 12 week period with<br />

an second generation antipsychotic would result in;<br />

91-200 people with behavioural disturbance showing clinically significant improvement in symptoms<br />

10 deaths<br />

(Evidence suggests that risk of mortality increases over time, therefore longer term treatment may result in<br />

up to 167 additional deaths over a 2 year period<br />

18 CVAEs of which ~50% would be severe<br />

(Evidence from observational studies suggests increased risk of CVAE may be confined to the 2-3 month<br />

period typically encompassed in RCT follow-up studies, therefore extrapolation of data in the original CSM<br />

alert, 2004, proposing that NNH of 37 would translate to NNH of 6.3 over 1 year, resulting in an additional<br />

159 CVAEs per 1000 people treated, may be an over-estimation).<br />

No additional falls or fractures<br />

58-94 people with gait disturbance<br />

Intervention<br />

Risperidone<br />

Olanzapine<br />

(Off-license use)<br />

Amisulpride<br />

(Off-license use)<br />

Aripiprazole<br />

(Off-license use)<br />

Quetiapine<br />

(Off-license use)<br />

First Generation<br />

antipsychotics<br />

(Off-license use)<br />

Rationale<br />

(Where stated, doses derived from published studies)<br />

Licensed for the short-term treatment (up to 6 weeks) of persistent<br />

aggression in patients with moderate to severe Alzheimer's dementia<br />

unresponsive to non-pharmacological approaches and when there is a risk of<br />

harm to self or others (500micrograms- 2mg/daily).<br />

Significant improvement in aggression & psychosis compared to placebo<br />

Significant improvement in aggression compared to placebo (5-10mg/daily)<br />

ONLY consider as a 2nd line option where risperidone not appropriate/not<br />

tolerated<br />

Reported doses prescribed 200mg/daily. Preliminary observation suggests<br />

that amisulpride may be useful to control agitation and disruptive behaviours.<br />

RCT (open prospective) demonstrated equivalent efficacy to risperidone.<br />

Only small open-label studies available. Evidence weak.<br />

Improvement in psychosis demonstrated with 2-15mg/day compared with<br />

placebo (Schneider et al 2006; NNT=13.8)<br />

Reported doses prescribed: 50-200mg/day. 200mg/day reported superior to<br />

placebo for agitation where 100mg/day not superior to placebo, BUT showed<br />

harm compared with placebo at 26 weeks for severe impairment battery (SIB)<br />

Potential risks outweigh possible benefits: (Associated with increased risk of<br />

CVE and mortality (mortality risk ≥ second generation antipsychotics)<br />

DPT use<br />

approved<br />

YES<br />

YES<br />

NO<br />

NO<br />

NO<br />

NO<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 7 of 10


ACETYL-CHOLINESTERASE INHIBITORS (If not already prescribed for management of AD)<br />

Intervention Rationale (Where stated, doses derived from published studies) DPT use<br />

approved<br />

Donepezil<br />

(Off-license use)<br />

Meta-analysis demonstrated a small by significant overall advantage of<br />

AChEIs over placebo with regard to the treatment of <strong>BPSD</strong> in Alzheimer’s<br />

Disease, although no short term benefit for treatment of clinically significant<br />

agitation with donepezil observed in 12 week RCT.<br />

Current evidence appears to demonstrate that AChEIs have their greatest<br />

effects on depression and dysphoria, apathy, indifference and anxiety and<br />

are probably not an effective treatment for the management of agitation or<br />

aggression in Alzheimer’s dementia.<br />

YES<br />

Galantamine<br />

(Off-license use)<br />

Rivastigmine<br />

(Off-license use)<br />

Evidence equivocal at doses of 16-24mg/day. In placebo controlled trials,<br />

Rockwood et al (2001) reported no statistically significant difference in<br />

behavioural symptoms between groups (n=386). Cummings et al (2004) post<br />

hoc analysis of Tariot et al (2000) reported slight improvement (NPI)<br />

observed with galantamine (p=0.04) at 16 & 24mg/day but not 8mg/d (n=978)<br />

Not approved because available evidence equivocal and increased treatment<br />

cost cannot be justified due to lack of evidence demonstrating increased<br />

efficacy compared with donepezil.<br />

Reported doses prescribed 1.5-4.5mg bd (6-12mg/day). Evidence equivocal<br />

(most studies open-label and behaviour a secondary end-point). Metaanalysis<br />

reported rivastigmine may be tolerated and effective for <strong>BPSD</strong> (6-<br />

12mg/d) (Finkel et al, 2004)<br />

Not approved because available evidence equivocal and increased treatment<br />

cost cannot be justified due to lack of evidence demonstrating increased<br />

efficacy compared with donepezil.<br />

NO<br />

NO<br />

NMDA ANTAGONIST<br />

Memantine Systemic meta- analysis suggested that memantine (10mg bd) decreases<br />

(Off-license use) NPI scores and may have a role in <strong>BPSD</strong> (reducing agitation/aggression) but<br />

effect size small. Could be considered for management of severe symptoms<br />

of agitation/aggression and psychosis in people who have failed to respond<br />

to other medication and who are otherwise prone to a rapid decline.<br />

Maidment et al (2008).<br />

However, a randomised DB PC trial (Fox et al 2012) reported no<br />

improvement in significant agitation in people with moderate to severe AD,<br />

suggesting that memantine should not be routinely prescribed to treatment<br />

agitation in AD.<br />

YES<br />

ANTIDEPRESSANTS<br />

Intervention Rationale (Where stated, doses derived from published studies) DPT use<br />

approved<br />

Mirtazapine<br />

(Off-license use)<br />

Citalopram<br />

(Off-license use)<br />

Trazadone<br />

(Off-license use)<br />

Limited evidence available. One 12 week open-label study reported<br />

mirtazapine (15-30mg/day) could be a well-tolerated treatment option for the<br />

management of agitation in people with Alzheimer’s Disease (AD).<br />

YES<br />

Whilst not clinically effective for the treatment of depression in people with<br />

AD, mirtazapine may act to improve general behavioural and psychological<br />

Banerjee (2013)<br />

symptoms in dementia rather than depression<br />

Limited, but encouraging, evidence available. More studies needed.<br />

Trazadone most widely used antidepressant prescribed for people presenting<br />

with <strong>BPSD</strong> despite lack of robust evidence to support efficacy.<br />

NO<br />

NO<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 8 of 10


BENZODIAZEPINES<br />

Intervention Rationale<br />

(Where stated, doses derived from published studies)<br />

Diazepam 1-2 mg up to 3 times a day (increase if necessary to<br />

(Off-license use) Max 15mg/24 in divided doses) Licensed for anxietyshort<br />

term use only for acute & severe distress<br />

and/or where sedation is required<br />

T1/2 ~32 hours (21-50) longer in older adults<br />

No systemic reviews of RCTs examining the<br />

usefulness of benzodiazepines in the management<br />

symptoms associated with dementia (including<br />

anxiety) were identified.<br />

Lorazepam<br />

(Off-license use)<br />

NB 5mg diazepam ~equiv to 0.5mg lorazepam<br />

Usual max dose= 2mg/24hours (in divided doses)<br />

Short term use for only for acute & severe distress<br />

and/or where sedation is required<br />

Licensed for anxiety<br />

T1/2 ~12 hours (8-25) Similar in older adults<br />

No systemic reviews of RCTs examining the<br />

usefulness of benzodiazepines in the management<br />

symptoms associated with dementia (including<br />

anxiety) were identified<br />

May<br />

cause/hasten<br />

cognitive decline<br />

Paradoxical<br />

disinhibition may<br />

occur<br />

Contribute to falls<br />

and hip fractures<br />

Accumulation<br />

leading to<br />

excessive<br />

sedation/adverse<br />

effects and/or<br />

tolerance over<br />

time<br />

DPT use<br />

approved<br />

YES<br />

ONLY<br />

for short<br />

term use for<br />

acute &<br />

severe<br />

distress<br />

and/or where<br />

sedation is<br />

required<br />

ANTI-CONVULSANTS:<br />

Intervention Rationale<br />

(Where stated, doses derived from published studies)<br />

Carbamazepine Uncontrolled studies & case reports have reported improvement in<br />

(Off-license use) presenting hostility & aggression in people with dementia who had not<br />

responded to antipsychotics as well as short term efficacy for agitation,<br />

however a review of placebo controlled RCTs to date provides equivocal<br />

information about efficacy for <strong>BPSD</strong>, and the safety and tolerability of<br />

therapeutic doses in people with dementia/older adults still needs to be<br />

established.<br />

DPT use<br />

approved<br />

NO<br />

Valproate<br />

(Off-license use)<br />

Adverse effects include: Impairment of balance & increased risk of falls,<br />

Drug interactions, Impaired cognition, Blood dyscraisias, Hyponatraemia,<br />

Hepatic dysfunction, Serious skin reactions<br />

Despite positive treatment responses documented in case reports,<br />

retrospective chart reviews and open-label studies, the existing d/b, p/c,<br />

RCTs do not support the proposal that valproate is effective in the<br />

management of agitation, aggression or other <strong>BPSD</strong> in people with<br />

dementia.<br />

NO<br />

Adverse effects include: GI side effects, Impaired cognition,<br />

Hepatotoxicity- monitor liver function before & during treatment<br />

Oxcarbazepine No evidence to demonstrate efficacy NO<br />

Gabapentin Limited data reporting treatment well tolerated and effective, but<br />

NO<br />

evidence weak (small open-label &case reports only) and incomplete.<br />

Pregabalin No available published evidence reporting use or efficacy for <strong>BPSD</strong> NO<br />

Lamotrigine<br />

Topiramate<br />

Limited data reporting treatment well tolerated and effective, but<br />

evidence very weak (case reports only).<br />

Limited data (non-random retrospective study n=15). Reduction in<br />

Cohen-Mansfield Agitation Inventory noted but evidence very weak.<br />

NO<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 9 of 10


References<br />

Alzheimer’s Society (2011) Optimising treatment and care for people with behavioural<br />

and psychological symptoms of dementia .A best practice guide for health and social<br />

care professionals.<br />

Available at http://www.alzheimers.org.uk/site/scripts/download_info.phpfileID=1163<br />

Ballard C.G.; Gauthier S.; Cummings J.L.; Brodaty H.; Grossberg G.T.; Robert P.;<br />

Lyketsos C.G. Management of agitation and aggression associated with Alzheimer<br />

disease<br />

Nature reviews. Neurology, May 2009, vol./is. 5/5(245-255),<br />

Ballard C.; Corbett A.; Chitramohan R.; Aarsland D. Management of agitation and<br />

aggression associated with Alzheimer's disease: Controversies and possible<br />

solutions Current Opinion in Psychiatry, November 2009, vol./is. 22/6(532-540),<br />

Banerjee S, Hellier J, Romeo R et al (2013) Study of the use of antidepressants for<br />

depression in dementia: the HTA-SADD trial- a multicentre, randomised, DB, PC trial of<br />

the clinical effectiveness and cost-effectiveness of sertraline and mirtazapine. Health<br />

Technol Assess 17(7) DOI: 10.3310/hta17070 www.alzheimers.org.uk/bpsdguide.<br />

Accessed 14 Aug 2013<br />

Bazire S (2012) Psychotropic Drug Directory 2012. Warwickshire.UK<br />

Cakir S, Kulaksizoglu I (2008) The efficacy of mirtazapine in agitated patients with<br />

Alzheimer’s Dementia: A 12 week open label pilot study. Neuropsychiatric Disease and<br />

Treatment 4(5) 963-966<br />

Corbett A.; Smith J.; Creese B.; Ballard C. Treatment of behavioral and psychological<br />

symptoms of Alzheimer's disease Current Treatment Options in Neurology, April<br />

2012, vol./is. 14/2(113-125),<br />

Fox C, Crugel M, Maidment I et al (2012) Efficacy of memantine for agitation in<br />

Alzheimer’s Dementia: A randomised double-blind placebo controlled trial PLoS ONE<br />

7(5): e35185 doi:10.1371/journal.pone.0035185<br />

Konovalov S, Muralee S, Tampi R (2007) Anticonvulsants for the treatment of<br />

behavioural and psychological symptoms of dementia: a literature review. International<br />

Psychogeriatrics 20:2, 293-308<br />

Pollock B.G.; Mulsant B.H.; Rosen J.; Mazumdar S.; Blakesley R.E.; Houck P.R.; Huber<br />

K.A. (2007) A double-blind comparison of citalopram and risperidone for the<br />

treatment of behavioral and psychotic symptoms associated with dementia The<br />

American journal of geriatric psychiatry, vol./is. 15/11(942-952)<br />

Pollock B.G.; Mulsant B.H.; Rosen J.; Sweet R.A.; Mazumdar S.; Bharucha A.; Marin R.;<br />

Jacob N.J.; Huber K.A.; Kastango K.B.; Chew M.L. (2002) Comparison of citalopram,<br />

perphenazine, and placebo for the acute treatment of psychosis and behavioral<br />

disturbances in hospitalized, demented patients American Journal of Psychiatry,<br />

vol./is. 159/3(460-465),<br />

National Institute for Health and Clinical Excellence (2006) Dementia (CG42): Supporting<br />

people with dementia and their carers in health and social care<br />

Seitz DP, Adunuri N, Gill SS, Gruneir A, Herrmann N, Rochon P. Antidepressants for<br />

agitation and psychosis in dementia. Cochrane Database of Systematic Reviews 2011,<br />

Issue 2. Art. No.: CD008191. DOI: 10.1002/14651858.CD008191.pub2<br />

PG 14 – Pharmacological Management of <strong>BPSD</strong><br />

Approved by Drug and Therapeutics Committee: September 2013<br />

Review date: September 2015<br />

Page 10 of 10

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