Table 23

Summary of study characteristics for RCTs of clozapine versus a FGA in people with schizophrenia whose illness has not responded adequately to treatment.

Clozapine vs. haloperidolClozapine vs. a non-haloperidol FGAa
k (total N)4 (607)3 (459)
Study IDBuchanan1998
Klieser1989
Rosenheck1997
VOLAVKA2002
Claghorn1987
Hong1997
Kane1988
Diagnostic criteriaDSM-III-R, DSM-IVDSM-II, DSM -III, DSM-IV
Selected inclusion criteria b c
SettingInpatient/outpatientInpatient
Duration of treatmentShort-term: 6–10 weeks
Medium-term: 14 weeks
Long-term: 52 weeks
Short-term: 4–8 weeks
Medium-term: 12 weeks
Medication dose (mg/day)CLZ: 400–552 mg/d (range of means); 100–900 mg/d (range)

HAL: 20–28 mg/d (range of means); 5–30 mg/d (range)
CLZ: 417–543 mg/d (range of means); 150–900 mg/d (range)

CHL: 798–1163 mg/d (range of means); 300–1800 mg/d (range)

a All three trials used chlorpromazine as the comparator.

b Buchanan1998: Non-complete response to at least two trials of therapeutic doses of antipsychotics for at least 6 weeks; Klieser1989: Chronic treatment-resistant (no diagnostic criteria); Rosenheck1997: Treatment-resistant, high level use of inpatient services; VOLAVKA2002: Sub-optimal response to previous treatment, defined by history of persistent positive symptoms after at least 6 contiguous weeks of treatment with one or more typical antipsychotics at ≥600 mg/d in CHL equivalents, and a poor level of functioning over past 2 years.

c Claghorn1987: Intolerant to at least two prior antipsychotics; Hong1997: Treatment-refractory (Severe psychotic symptoms according to BPRS item scores for >6 months despite treatment with antipsychotics from at least two different classes at dosages of at least 1000 mg CHL equivalents); Kane 1988: 3+ periods of antipsychotic treatment, 1000 mg/day of CHL equivalents without significant symptomatic relief & BPRS total score of at least 45.

From: 6, Pharmacological interventions in the treatment and management of schizophrenia

Cover of Schizophrenia
Schizophrenia: Core Interventions in the Treatment and Management of Schizophrenia in Primary and Secondary Care (Update) [Internet].
NICE Clinical Guidelines, No. 82.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2009 Mar.
Copyright © 2009, National Collaborating Centre for Mental Health.

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