Change from Haloperidol to Olanzapine in schizophrenic patients: an open study

Not Applicable

Completed

Conditions: -F20
F20

Registration Number: PER-041-00

Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

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

• 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.