NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

1
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

2
Context

• 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)

3
Context (cont.)

• Effective Health Care Bulletins, Cochrane Reviews
  etc. (1999-2002)
• 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)

4
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)
• lthttp//www.nice.org.ukgt
• NHS Responseline 08701 555 455
• ltdoh_at_prologistics.co.ukgt

5
Policy Implementation Guidelines (PIGs)
Can we make them a reality ?
6
Outcomes of schizophrenia

• 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

7
Outcomes of schizophrenia (cont.)

• 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

8
Other outcomes of schizophrenia

• 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

9
Other outcomes of schizophrenia (cont.)

• 10 of those diagnosed with schizophrenia commit
  suicide
• Significantly higher risk of Accidents and
  Cardio-vascular disease
• Frangou and Murray 1996

10
Principles of NICE care

• 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

11
Principles of NICE care (cont.)

• Language and culture
• Advance directives

12
Care across three phases

• Initiation of treatment at the first episode
• Acute phase
• Promoting recovery

13
Initiation of treatment (First episode)

• Early Referral
• All people with suspected or newly diagnosed
  schizophrenia presumed diagnosis of schizophrenia
  - assessment by a Consultant Psychiatrist.

14
Initiation of treatment (First episode)

• Early Intervention
• Early Intervention Services
• Where needs of the user exceeds capacity,
  referral to crisis resolution/ home treatment/
  acute day services/ inpatient services

15
Initiation of treatment (First episode)

• Pharmacological Interventions
• Oral atypical antipsychotic drugs choice of first
  time treatments at the lower end of the standard
  dose range.

16
Initiation of treatment (First episode)

• Second Opinion
• Support a decision by a service users to seek a
  second opinion

17
Treatment of the acute episode

• 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

18
Service level interventions

• crisis resolution
• home treatment teams
• early intervention and YP services
• assertive outreach
• community mental health teams
• acute day hospitals
• in patient care

19
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

20
Early post-acute period care

• 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.

21
Early post-acute period care

• Psychological and family help, contingency
  planning and identify local resources/services
• Advice about drug treatments to maintain recovery
  

22
Promoting recovery

• Primary care
• Secondary care
• Service Interventions
• Psychological interventions
• Pharmacological interventions
• Employment

23
Cognitive Behaviour Therapy

• 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

24
Family Interventions

• 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

25
Pharmacological intervention - all phases

• 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.

26
Pharmacological intervention - all phases

• 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.

27
Pharmacological intervention - all phases

• 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)

28
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.

29
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

30
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

31
(No Transcript)
32
NICE - The Evidence

• Evidence to support core interventions in the
  treatment and management of schizophrenia in
  primary and secondary care

33
Type of evidence

• 1a - Evidence obtained from a single large
  randomised trial or meta-analysis of at least 3
  RCTs.
• 1b - Evidence obtained from a small randomised
  controlled trial or a meta-analysis of less than
  3 RCTs.

34
Pharmacological Interventions

• 172 RCTs 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 RCTs were 4 to 8
  weeks long with 31 being over 6 months duration.

35
Considerations

• 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.

36

• 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.

37
Evidence

• 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.

38
Evidence

• 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.
• Little evidence of comparative rates of tardive
  dyskinesia between the atypicals or between the
  typical and atypicals.

39
Evidence

• 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.

40
Clozapine

• 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.

41
Recommended Drugs

• Amisulpride
• Olanzapine
• Quetiapine
• Risperidone
• Zotepine

42
Cognitive Behavioural Therapy

• Total of 13 RCTs 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.

43
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.

44
Effect of CBT upon symptoms

• 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.

45
Other effects of CBT

• 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.

46
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.

47
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

48
Evidence

• 18 RCTs 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)

49
Results

• 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 post-treatment follow up -
  1a.
• Hospital admission 13 to 24 months into treatment
  - 1a.

50
Results

• 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 post-treatment - 1b.

51
Clinical summary - FI

• 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.

52
(No Transcript)
53
(No Transcript)