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For specific information about the pharmacology of lithium or valproate, refer to the CLINICAL PHARMACOLOGY section of the package inserts for these other products. Clinical Efficacy Data
Schizophrenia The efficacy of olanzapine in the treatment of schizophrenia was established in 2 short-term (6-week) controlled trials of inpatients who met DSM III-R criteria for schizophrenia. A single haloperidol arm was included as a comparative treatment in one of the two trials, but this trial did not compare these two drugs on the full range of clinically relevant doses for both. Several instruments were used for assessing psychiatric signs and symptoms in these studies, among them the Brief Psychiatric Rating Scale (BPRS), a multi-item inventory of general psychopathology traditionally used to evaluate the effects of drug treatment in schizophrenia. The BPRS psychosis cluster (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) is considered a particularly useful subset for assessing actively psychotic schizophrenic patients. A second traditional assessment, the Clinical Global Impression (CGI), reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient. In addition, two more recently developed but less well evaluated scales were employed; these included the 30-item Positive and Negative Symptoms Scale (PANSS), in which is embedded the 18 items of the BPRS, and the Scale for Assessing Negative Symptoms (SANS). The trial summaries below focus on the following outcomes: PANSS total and/ or BPRS total; BPRS psychosis cluster; PANSS negative subscale or SANS; and CGI Severity. The results of the trials follow: Text Continues Below
(1) In a 6-week, placebo-controlled trial (n= 149) involving two fixed olanzapine doses of 1 and 10 mg/ day (once daily schedule), olanzapine, at 10 mg/ day (but not at 1 mg/ day), was superior to placebo on the PANSS total score (also on the extracted BPRS total), on the BPRS psychosis cluster, on the PANSS Negative subscale, and on CGI Severity. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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