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Clozapine and Haloperidol in Moderately Refractory Schizophrenia
A 6-Month Randomized and Double-blind Comparison
John M. Kane, MD;
Stephen R. Marder, MD;
Nina R. Schooler, PhD;
William C. Wirshing, MD;
Daniel Umbricht, MD;
Robert W. Baker, MD;
Donna A. Wirshing, MD;
Allan Safferman, MD;
Rohan Ganguli, MD;
Marjorie McMeniman, PhD;
Michael Borenstein, PhD
Arch Gen Psychiatry. 2001;58:965-972.
Background Despite the demonstrated efficacy of clozapine in severely refractory
schizophrenia, questions remain regarding its efficacy for primary negative
symptoms, comparison with a moderate dose of a first-generation antipsychotic,
and adverse effects during a longer-term trial. This study examined its efficacy
in partially responsive, community-based patients, compared clozapine with
moderate-dose haloperidol, and extended treatment to 6 months.
Methods Randomized, double-blind, 29-week trial comparing clozapine (n = 37)
with haloperidol (n = 34). Subjects with schizophrenia who were being treated
in community settings at 3 collaborating clinical facilities were enrolled.
Results Subjects treated with haloperidol were significantly more likely to
discontinue treatment for lack of efficacy (51%) than were those treated with
clozapine (12%). A higher proportion of clozapine-treated subjects met an
a priori criterion of improvement (57%) compared with haloperidol-treated
subjects (25%). Significantly greater improvement was seen in symptoms of
psychosis, hostile-suspiciousness, anxiety-depression, thought disturbance,
and total score measured on the Brief Psychiatric Rating Scale. No differences
were detected in negative symptoms using the Brief Psychiatric Rating Scale
or the Schedule for Assessment of Negative Symptoms. Subjects treated with
clozapine experienced more excess salivation, dizziness, and sweating and
less dry mouth and decreased appetite than those treated with haloperidol.
Conclusions Compared with a first-generation antipsychotic given in a moderate dose,
clozapine offers substantial clinical benefits to treatment-refractory subjects
who can be treated in the community. Advantages are seen in a broad range
of symptoms but do not extend to negative symptoms.
From the Department of Psychiatry, Hillside Hospital, North Shore–Long
Island Jewish Health System, Glen Oaks, NY (Drs Kane, Umbricht, Safferman,
McMeniman, and Borenstein); the Department of Psychiatry, West Los Angeles
Veterans Affairs Medical Center, Los Angeles, Calif (Drs Marder, W. C. Wirshing,
and D. A. Wirshing); and the Western Psychiatric Institute and Clinic, Department
of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pa
(Drs Schooler, Baker, and Ganguli). Dr Schooler is now with the Department
of Psychiatry, Hillside Hospital; Dr Umbricht, the Department of Psychiatry,
Psychiatric University Hospital, Zurich, Switzerland; Dr Baker, Eli Lilly
and Company, Indianapolis, Ind; and Dr Safferman, Pfizer Pharmaceuticals,
New York, NY.
Corresponding author and reprints: John M. Kane, MD, Hillside Hospital,
Glen Oaks, NY 11004.
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