None listed
Conditions
Interventions
Patients will start therapy with 10 mg. of olanzapine once a day. The dose should be adjusted upwards within the allowed range of 10 to 20 mg of olanzapine based on the patients clinical status. Dose reductions due to adverse events could occur at any time in decreases of 5 mg.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Women or men, from 18 to 65 years of age in the visit 1. • Female patients with gestational potential should use a medically accepted means of contraception. • Each patient must have a sufficient level of understanding to communicate intelligently with the researcher, nurse and study coordinator. • Patients must be reliable. They must agree to cooperate with all the tests and exams required by the protocol. • Each patient (or authorized legal representative of the patient) must understand the nature of the study and sign an informed consent. • Patients must meet the criteria for schizophrenia defined in the DSMIV. • Patients must have been treated with haloperidol for a minimum of 6 weeks before entering the study. • Patients must have a total SAS score of> 3.
Exclusion criteria
Exclusion criteria: • Women who are pregnant or nursing. • Severe illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinological, neurological, immunological or hematological diseases, such as anticipating hospitalization within 3 months or death within 3 years. • Hyperthyroidism or hyperthyroidism uncorrected. • Acute angle glaucoma. • One or more attacks without a clear and determined etiology. Leukopenia or history of leukopenia without a clear and determined etiology. • History of severe allergies or adverse reactions to multiple medications. • Abuse or dependence of any substance (alcohol or other drugs) within the previous 3 months. • Judged clinically as seriously at risk of suicide. • Participation in a clinical trial of another research substance within 1 month (30 days) before entering the study (visit 1). • Any other medication concomitant with primary activity of the central nervous system, different from that specified in section 3.8. • Treatment with a neuroleptic injectable deposit prior to visit 1. • Previous exposure to olanzapine. • Treatment with lithium, anticonvulsants, benzodiazepines, antidepressants (except fluoxetine), psychostimulants, reversible monoamine oxidase monoamine oxidase inhibitors, reserpine, guanethidine or guanadrel, within week 1 before visit 2. • Any patient treated with clozapine within 4 weeks prior to visit 2. • Treatment with inhibitors of the non-reversible monoamine oxidase within 2 weeks prior to visit 2. • Fluoxetine treatment within 4 weeks prior to visit 2. • The use of anticholinergics as prophylaxis is prohibited. • More than 20 mg. of haloperidol the last 2 days before the visit 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Determination of patient improvement in BPRS, PANSS and CGI severity scales. Measure:Efficacy Timepoints:The BPRS and PANSS will be evaluated in visits 1, 2, 3, 4, 6 and 8 or in the final visit, the severity scale CGI will be administered in all visits. ; Outcome name:Psychiatric exams, physical exams (electrocardiography) Measure:Safety Timepoints:At visit 1, a medical history will be taken, as well as psychiatric and physical exams including electrocardiography. The physical examination and electrocardiography will be repeated after 6 weeks of open therapy and at any time if the patient discontinues after the visit 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Quality of life scale (QLS). The QLS determines the quality of life in regards specifically to schizophrenia. Measure:Quality of Life Timepoints:The quality of life scale (QLS) will be administered to outpatients only on visits 2 and 8. | — |
Outcome results
None listed