Clozapine in Treatment-Resistant Patients With Schizophrenia, Schizoaffective Disorder, or Psychotic Bipolar Disorder: A Naturalistic 48-Month Follow-Up Study
J Clin Psychiatry 2003;64(4):451-458
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: The aim of this study was to
evaluate the long-term efficacy and safety of clozapine in
patients with treatment-resistant schizophrenia, schizoaffective
disorder, or bipolar disorder with psychotic features.
Method: 101 patients with a DSM-III-R diagnosis
of schizophrenia (N = 34); schizoaffective disorder, bipolar type
(N = 30); or bipolar disorder with psychotic features (N = 37)
were naturalistically treated with clozapine at flexible doses
over a 48-month period. Data were collected from 1994 to 2000.
The Brief Psychiatric Rating Scale (BPRS) and Clinical Global
Impressions-Severity of Illness scale total predicted scores over
time were estimated with random-effects regression models. Time
to response to clozapine, defined as 50% reduction of BPRS score,
was analyzed in the 3 diagnostic groups using the Kaplan-Meier
method. Survival curves were compared using the log-rank test.
Results: The BPRS total predicted score halved
its baseline value in 3 months for bipolar disorder patients, in
6 months for schizoaffective disorder patients, and in 24 months
for schizophrenia patients. The proportion of subjects who
satisfied the criterion for response to clozapine after 48 months
of follow-up was significantly (p < .01) higher in the
schizoaffective and bipolar disorder groups (90.0% and 83.8%,
respectively) than in the schizophrenia group (64.7%). Baseline
scores on the Global Assessment of Functioning (GAF) showed low
levels of psychosocial and occupational functioning in all 3
groups. After 48 months of treatment, GAF scores showed a
functional improvement in all 3 groups, with significantly (p
< .01) greater improvement in the bipolar disorder group
compared with the other groups.
Conclusion: The findings of this study confirm
the efficacy and safety of clozapine for treatment-resistant
patients with a diagnosis of schizophrenia, schizoaffective
disorder, or bipolar disorder with psychotic features. Patients
with schizoaffective disorder and those with bipolar disorder
show greater clinical improvement than those with schizophrenia.
Patients with bipolar disorder have the shortest time to response
and the highest psychosocial and occupational functioning levels.
Patients with schizoaffective disorder have the lowest treatment