Summary of Study Design This is a randomized, double-blind, flexible-dosed, parallel study
exploring the relationship between early response to an antipsychotic medication and
subsequent improvement in psychopathology using the atypical antipsychotic risperidone, and
determining if patients who do not show an early response to risperidone can achieve an
adequate improvement in clinical status following 10 weeks of treatment with olanzapine.
Inclusion Criteria:
1. Male or female patients, 18 to 65 years of age
2. All female patients must test negative for pregnancy.
3. Patients must have schizophrenia, schizoaffective disorder, or schizophreniform
disorder.
4. Patients must meet the following psychopathologic severity criteria at Visit 1: total
Brief Psychiatric Rating Scale (BPRS) score extracted from the PANSS of at least 45.
5. Patients must receive a minimum Clinical Global Impression-Severity (CGI-S) scale
rating of 4 (moderately ill) or greater at Visit 1.
6. Patients must have experienced an exacerbation of their illness within the 2 weeks
preceding Visit 1, that has led to an intensification of the level of psychiatric
care.
7. Patients in whom a switch to another antipsychotic medication is acutely indicated.
8. Patients must be considered reliable, have a level of understanding sufficient to
perform all tests and examinations. 4. 1.1. Disease Diagnostic Criteria For the
purposes of this study, patients with schizophrenia, schizoaffective disorder, or
schizophreniform disorder.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
1. Are investigator site personnel directly affiliated with the study, or are immediate
family of investigator site personnel directly affiliated with the study.
2. Are employed by Lilly (that is, employees, temporary contract workers, or designees
responsible for conducting the study).
3. Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.
4. Patients in whom risperidone or olanzapineis clinically contraindicated.
5. Patients who have a history of inadequate response to risperidone or olanzapine.
6. Patients who have been hospitalized for greater than 2 weeks immediately prior to
Visit 1.
7. Patients having received olanzapine or risperidone in the past 30 days.
8. Patients needing a thyroid hormone supplement to treat hypothyroidism must have been
on a stable dose of medication for at least 2 months prior to Visit 1.
9. Patient required concomitant treatment with any other medication with primary central
nervous system activity, other than those allowed as specified in section 5. 7 below.
10. Patients on treatment with depot antipsychotics within one dosing interval or minimum
of 2 weeks prior to Visit 1.
11. Actively suicidal (e. g. any suicide attempts within the past month or any current
suicidal intent including plan) in the opinion of the investigator.
12. History of allergic reaction to olanzapine or risperidone.
13. Female patients who are either pregnant or nursing.
14. Known uncorrected narrow-angle glaucoma.
15. One or more seizures without a clear and resolved etiology.
16. Have leukopenia or history of leukopenia.
17. Treatment with clozapine within 1 year prior to Visit 1.
18. ALT/SGPT values > 2 times the upper limit of normal of the performing laboratory (ULN)
or AST/SGOT values > 3 times the ULN or total bilirubin values > 1. 5 times the ULN at
Visit 1.
19. Serious, unstable illnesses such that death is anticipated within 1 year or intensive
care unit hospitalization for the disease is anticipated within 6 months.
20. Patients with acute, serious or unstable medical conditions.
21. Prolactin level at Visit 1 of greater than 200 ng/mL (or 200ug/L).
22. Patients who have had electroconvulsive therapy within 3 months of Visit 1 or who will
have ECT at any time during the study.
23. Diagnosis of substance-induced psychosis.
24. A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.
25. Patients with a QTc interval (Bazzett's) >450 msec (male) or >470 msec (female) at
Visit 1
