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NATIONAL INSTITUTE FOR
CLINICAL EXCELLENCE
• Core Interventions in the
Treatment and Management of
Schizophrenia in Primary and
Secondary Care
• Guidance on the use of the
newer (atypical) antipsychotic
drugs for the treatment of
schizophrenia
John Rawlinson
Andy Carberry
Context
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CPA 1990,
Health of the Nation (DoH 1992)
‘Serious and Enduring Mental
Illness’ and suicide risk
Clinical Standards Advisory Group Schizophrenia (CSAG 1995)
Family, PSI, Pharmacology, EI, AO,
etc,
Evidence Based Practice
(EBM/EBP)
Context (cont.)
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Effective Health Care Bulletins,
Cochrane Reviews etc. (19992002)
National Service Framework for
Mental Health (DoH 1999)
‘Recent advances in understanding
mental illness and psychotic
experiences’ (BPS 2000)
Mental Health Policy
Implementation Guide and other
PIGs (DoH 2001on)
Context (cont.)
•
Guidance on the use of newer
(atypical) antipsychotic drugs for
the treatment of schizophrenia
(NICE 2002)
• Core Interventions in the treatment
and management of schizophrenia
in primary and secondary care
(NICE 2002)
<http://www.nice.org.uk>
NHS Responseline: 08701 555 455
<[email protected]>
Policy Implementation
Guidelines (PIGs)
Can we make them a reality ?
Outcomes of
schizophrenia
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22-25%: Have a single diagnosed
episode with no resulting clinical or
social impairment
35%:
Have occasional
recurrences with no or minimal
impairment between episodes
8%:
Experience some social
impairment after the first acute
episode persisting unaffected by
further breakdowns
Outcomes of
schizophrenia (cont.)
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35%:
Are increasingly
damaged by each subsequent
acute crisis so that social
functioning worsens progressively
50%
Of those treated in
standard services relapse requiring
readmission in the first 2 years
(1% lifetime risk in general population
across all cultures)
Frangou and Murray 1996, Mason et al
1996 in NICE2002
Other outcomes of
schizophrenia
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Negative social reactions to
symptoms and behaviour, with
consequences such as stigma,
discrimination, high
unemployment, failed or
impoverished relationships etc..
10 years shorter lifespan than the
general population
Other outcomes of
schizophrenia (cont.)
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10% of those diagnosed with
schizophrenia commit suicide
Significantly higher risk of
Accidents and Cardio-vascular
disease
Frangou and Murray 1996
Principles of NICE
care
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Optimism
Getting help early
Comprehensive Assessment medical, psychological,
occupational, economic, physical
and cultural
Partnership with users and carers
Consent and engagement
Good information and mutual
support
Principles of NICE
care (cont.)
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Language and culture
Advance directives
Care across three
phases
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Initiation of treatment at the first
episode
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Acute phase
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Promoting recovery
Initiation of treatment
(First episode)
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Early Referral
All people with suspected or
newly diagnosed
schizophrenia presumed
diagnosis of schizophrenia assessment by a Consultant
Psychiatrist.
Initiation of treatment
(First episode)
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Early Intervention
Early Intervention Services
Where needs of the user exceeds
capacity, referral to crisis
resolution/ home treatment/
acute day services/ inpatient
services
Initiation of treatment
(First episode)
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Pharmacological Interventions
Oral atypical antipsychotic drugs
choice of first time treatments
at the lower end of the
standard dose range.
Initiation of treatment
(First episode)
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Second Opinion
Support a decision by a service
users to seek a second
opinion
Treatment of the acute
episode
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Service level intervention
Pharmacological intervention
Broad range of social, group and
physical activities essential
elements
Mental Health Act and or inpatient
treatment may prove necessary
Service level
interventions
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crisis resolution
home treatment teams
early intervention and YP services
assertive outreach
community mental health teams
acute day hospitals
in patient care
Core interventions in the
management of
schizophrenia
Early Post acute period
• User focus
• Assessment
• Psychological treatments
including CBT and family work
• Medication advice
Promoting Recovery - Primary and
Secondary services
Preventing Relapse - ongoing
psychological and pharmacological
intervention
Early post-acute
period care
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Help to users better understand
the period of illness, and be given
the opportunity to write their
account in their notes.
Carers may need help in
understanding the experience.
Assessment for further help to
minimise disability, reduce risk and
improve quality of life.
Early post-acute
period care
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Psychological and family help,
contingency planning and identify
local resources/services
Advice about drug treatments to
maintain recovery
Promoting recovery
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Primary care
Secondary care
Service Interventions
Psychological interventions
Pharmacological interventions
Employment
Cognitive Behaviour
Therapy
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Cognitive behavioural therapy
(CBT) should be available as a
treatment option for people with
schizophrenia - A
In particular, cognitive behavioural
therapy should be offered to
people with schizophrenia who are
experiencing persisting psychotic
symptoms - A
Family Interventions
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Family interventions should be
available to the families of people
with schizophrenia who are living
with or who are in close contact
with the service user – A
Pharmacological
intervention
- all phases
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Antipsychotic drugs are
necessary.
Service users should make an
informed choice of antipsychotic
Single drug, using doses within
the BNF dose range
Clinical response and side effects
monitored routinely and
regularly.
Pharmacological
intervention
- all phases
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Oral atypical drugs should be
considered as the treatment option
of choice
Dosage of conventional
antipsychotic in the range of
300-1000mg Chlorpromazine
equivalents/day for a min. 6
weeks. Reasons for doses outside
this range should be justified and
documented. The minimum
effective dose should be used.
If side effects are troublesome or
symptom control inadequate,
atypical should be offered.
Pharmacological
intervention
- all phases
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Massive loading doses “rapid
neuroleptization” should not
be used.
Rapid tranquillisation may be
required in the acute phase
(lorazepam, haloperidol or
olanzapine) (see section 1.5)
Pharmacological
intervention recovery
phase
Relapse prevention – oral
antipsychotic
• Antipsychotic drugs are
indispensable option for most
people in the recovery phase
• Choice of antipsychotic made
jointly by individual and clinician
• Antipsychotic therapy part of a
comprehensive package of care
that addresses clinical emotional
and social needs.
Pharmacological
intervention recovery
phase
Relapse Prevention – depot
antipsychotic
• A risk assessment should be
performed
• Initiation of depot antipsychotic
injection should take into account
the preferences and attitudes of
the service user
Pharmacological
intervention recovery
phase
Treatment – Resistant Schizophrenia
• Antipsychotic drugs adequately
tried - dosage, duration,
adherence.
• Atypical antipsychotic in advance
of diagnosis of treatment resistant
schizophrenia.
• Treatment resistant schizophrenia Clozapine
NICE - The Evidence
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Evidence to support core
interventions in the treatment and
management of schizophrenia in
primary and secondary care
Type of evidence
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1a - Evidence obtained from a
single large randomised trial or
meta-analysis of at least 3 RCT’s.
1b - Evidence obtained from a
small randomised controlled trial or
a meta-analysis of less than 3
RCT’s.
Pharmacological
Interventions
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172 RCT’s reviewed with evidence
from 29 ‘head to head’ trials of
typical agents.
In addition 53 other studies were
considered which were either case
control, had more than 2 years of
follow up, or included more than
2000 participants.
The overwhelming majority of
RCT’s were 4 to 8 weeks long with
31 being over 6 months duration.
Considerations
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Limited by lack of long term follow
up, high attrition rates and the
inadequacy of the collection and
reporting of adverse effects.
Haloperidol which may be
associated with a higher rate of
EPS than other typicals was used
as the comparitor in many of the
trials.
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The generalisability of individual
study results was limited by the
exclusion of elderly people as well
as individuals with TRS,
predominantly negative symptoms,
learning disabilities, co-morbid
depression and substance abuse
disorders.
Evidence
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Atypical antipsychotics are at least
efficacious as the typical agents in
terms of overall response rates.
Variation in their relative effects on
positive and negative symptoms
and relapse rates.
Inadequate data to enable
separate evaluation of the overall
impact of individual atypicals on
schizophrenia.
Evidence
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All atypicals are associated with a
reduced incidence of EPS
compared to typicals in the short
to medium term (up to 26 weeks).
In the long term (26 weeks or
longer) there are limited data to
support a reduced incidence of EPS
with some of the atypicals.
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Little evidence of comparative
rates of tardive dyskinesia between
the atypicals or between the
typical and atypicals.
Evidence
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The side effect profiles of
individual atypicals may differ but
definitive statements relating to
differences between them are
difficult to make because of
variations in the evidence base for
individual drugs and in the length
of treatment follow up.
Clozapine
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Evidence suggests that in
individuals who have not
responded to previous
antipsychotic therapy then
clozapine is associated with fewer
relapses and greater clinical
improvement than typical agents.
Recommended Drugs
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Amisulpride
Olanzapine
Quetiapine
Risperidone
Zotepine
Cognitive Behavioural
Therapy
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Total of 13 RCT’s included in the
review, providing data on 1297
participants. All in these trials were
also receiving antipsychotic drugs,
and most often CBT was targeted
at individuals with long standing or
treatment resistant psychosis.
Control groups received ‘standard
care’, recreational activities,
befriending or supportive
counselling.
Effect of CBT upon
suicide & relapse rates
Insufficient evidence • When compared to ‘standard care’
during treatment -1b
• When compared to ‘standard care’
at 12 months post-treatment follow
up - 1b
• When compared to other
psychological treatments at 1-2
years post-treatment follow up 1a.
Effect of CBT upon
symptoms
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Limited evidence that CBT reduces
symptoms when compared to
‘standard care’ at end of treatment
- 1b.
Strong evidence that CBT improves
mental state when compared to
‘standard care’ at end of treatment
- 1a.
Limited evidence that CBT reduces
symptoms when compared to
other psychological interventions at
the end of treatment - 1b.
Other effects of CBT
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Adherence to drug treatment when
compared to ‘non specific
counselling’- 1b.
Improvements in insight,
compared to other treatments, at
12 months and 5 year follow up 1b.
Improvements in social
functioning, when compared to
‘non standard care’ - 1b.
Clinical summary -CBT
Overall there is good evidence that
CBT reduces symptoms for people
with schizophrenia at up to 1 year
follow up when compared to ‘standard
care’ and other treatments. The
evidence is stronger when CBT is used
for the treatment of persisting
psychotic symptoms rather than for
acute symptoms.
Family Interventions
Family sessions with a specific
supportive or treatment function
based on systemic, cognitive
behavioural or psychoanalytic
principles which must contain at
least 1 of the following • Psycho-educational intervention.
• Problem solving/crisis management
work.
• Interventions with the service user
Evidence
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18 RCT’s with data for 1458 study
participants and their families.
Comparator interventions included
‘standard care’ (11 studies), or
‘non standard care’ (standard care
plus general family support - 5
studies)
Results
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There is strong evidence that
family interventions, when
compared to all other
interventions, decrease the
likelihood of:
Relapse during treatment - 1a.
Relapse 4 to 15 months posttreatment follow up - 1a.
Hospital admission 13 to 24
months into treatment - 1a.
Results
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There is limited evidence that
family interventions, when
compared to all other treatments,
reduce the likelihood of:
Relapse in people with persisting
symptoms, after 12 months of
treatment - 1b.
Relapse in people with persisting
symptoms up to 6 months posttreatment - 1b.
Clinical summary - FI
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Overall there is strong evidence
that FIs improve the outcomes for
people with schizophrenia living
with, or having close contact with,
their family, most notably in
reducing the relapse rate both
during treatment and for up to 15
months after treatment has ended.