Lf. Fabre et al., ICI-204,636, A NOVEL, ATYPICAL ANTIPSYCHOTIC - EARLY INDICATION OF SAFETY AND EFFICACY IN PATIENTS WITH CHRONIC AND SUBCHRONIC SCHIZOPHRENIA, Clinical therapeutics, 17(3), 1995, pp. 366-378
We evaluated the effects of ICI 204,636 in 12 hospitalized patients wi
th schizophrenia in a double-blind, placebo-controlled, parallel-group
, rising-dose study. Patients met the Diagnostic and Statistical Manua
l of Mental Disorders, Third Edition, Revised criteria for chronic or
subchronic schizophrenia and had a total score greater than or equal t
o 30 on the 18-item Brief Psychiatric Rating Scale (BPRS) and a score
greater than or equal to 3 on the Clinical Global Impression (CGI) Sev
erity of Illness item. Patients received 21 days of double-blind treat
ment with increasing doses of ICI 204,636 (25 to 250 mg/d) or placebo.
Efficacy was assessed using the BPRS and CGI. Response to treatment w
as defined as a greater than or equal to 30% decrease in the BPRS tota
l score from baseline. Extrapyramidal symptoms and abnormal involuntar
y movements were assessed using the Simpson Scale and Abnormal Involun
tary Movement Scale.