Change from Haloperidol to Olanzapine in schizophrenic patients: an open study
- Conditions
- -F20F20
- 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
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Determination of patient improvement in BPRS, PANSS and CGI severity scales.<br>Measure:Efficacy<br>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.<br>;<br>Outcome name:Psychiatric exams, physical exams (electrocardiography)<br>Measure:Safety<br>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.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Quality of life scale (QLS). The QLS determines the quality of life in regards specifically to schizophrenia.<br>Measure:Quality of Life<br>Timepoints:The quality of life scale (QLS) will be administered to outpatients only on visits 2 and 8.<br>