Jm. Kane et al., Clozapine and haloperidol in moderately refractory schizophrenia - A 6-month randomized and double-blind comparison, ARCH G PSYC, 58(10), 2001, pp. 965-972
Background: Despite the demonstrated efficacy of clozapine in severely refr
actory schizophrenia, questions remain regarding its efficacy for primary n
egative symptoms, comparison With a moderate dose of a first-generation ant
ipsychotic, and adverse effects during a longer-term trial. This study exam
ined its efficacy in partially responsive, community-based patients, compar
ed clozapine with moderate-dose haloperidol, and extended treatment to 6 mo
nths.
Methods: Randomized, double-blind, 29-week trial comparing clozapine (n = 3
7) with haloperidol (n = 34). Subjects with schizophrenia who were being tr
eated in community settings at 3 collaborating clinical facilities were enr
olled.
Results: Subjects treated with haloperidol were significantly more likely t
o discontinue treatment for lack of efficacy (51%) than were those treated
with clozapine (12%). A higher proportion of clozapine- treated subjects me
t an a priori criterion of improvement (57%) compared with haloperidol-trea
ted subjects (25%). Significantly greater improvement was seen in symptoms
of psychosis, hostile-suspiciousness, anxiety-depression, thought disturban
ce, and total score measured on the Brief Psychiatric Rating Scale. No diff
erences were detected in negative symptoms using the Brief Psychiatric Rati
ng Scale or the Schedule for Assessment of Negative Symptoms. Subjects trea
ted with clozapine experienced more excess salivation, dizziness, and sweat
ing and less dry mouth and decreased appetite than those treated with halop
eridol.
Conclusions: Compared with a first-generation antipsychotic given in a mode
rate dose, clozapine offers substantial clinical benefits to treatment-refr
actory subjects who can be treated in the community. Advantages are seen in
a broad range of symptoms but do not extend to negative symptoms.