OLANZAPINE VERSUS ZIPRASIDONE IN THE TREATMENT OF SCHIZOPHRENIA

Not Applicable

• Conditions: -F20; F20

• Registration Number: PER-066-01
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-10-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Men or women between 18 and 75 years of age.
• Women with reproductive potential should be using a medically accepted method of contraception.
• Individuals who are reliable, who have a sufficient level of understanding to perform all the tests and exams required by the protocol, who can understand the nature of the study and who have given their informed consent.
• Patients must meet the diagnostic criteria for schizophrenia (295.10, 295.20, 295.30, 295.90) according to the definition of the Manual of Statistics and Diagnosis of Mental Disorders, Fourth Edition (DSM-IV).
• At Visit 1, patients must have an initial score greater than or equal to 42 (on a scale of -7) on the BPRS Scale drawn from the PANSS Scale, including a score of 4 or higher on one of the positive items of the PANSS Scale. Patients must also have a minimum score of 4 on the CGI-S Scale.

Exclusion Criteria

• Researchers, staff of the center directly affiliated with this study and their direct families. The direct family is defined as the spouse, father, son or brother, whether biological or legally adopted.
• Congenital long QT syndrome, or QTc interval of> 500 mSeg in Visits 1 or 2 or any of the following abnormalities on the ECG (which is known to confuse the QT interval measurement) that occur in Visits 1 or 2: PR> 250 msec, AV block in 2nd or Ser grade, Defect in intraventricular conduction with QRS duration> 120 msec, Left Branch Block, Blockage, Right Branch, Left Ventricular Hypertrophy, Wolff Parkinson White Syndrome
• Clinically significant abnormal laboratory results in the randomization when performing the pre-selection (screening) in Visit 1 that could be an impediment for the patient to continue in the study. Patients with prolonged uncorrected hypokalemia (<3.4 meq / 1) or hypomagnesemia (• Treatment with any medication during the last 30 days that has not received regulatory approval at the time of entering the study.
• Participation in a clinical trial with another medication, including olanzapine, within a period of 1 month (30 days) before entering the study (Visit 1).
• Treatment with an injectable depot neuroleptic within the period of 1 treatment cycle prior to Visit 1.
• Treatment with clozapine within 7 days of enrolling in the study.
• Individuals who have used olanzapine or ziprasidone within 6 months of the start of the trial, and whose treatment has been interrupted due to clinically significant and / or intolerable adverse effects, or who have exhibited a lack of efficacy / response to treatment.
• A prolactin level of> 200 mg / mL in Visit 1 (300 mg / mL for those patients who are receiving risperidone before Visit 1).
• Individuals who have completed or who have previously withdrawn from this study.
• Pregnant or lactating women.
• Serious, unstable diseases, in which the patient is expected to die within a period of one year, or it is anticipated that the patient will require hospitalization in the intensive care unit within a period of 6 months. These include liver disease (specifically, any degree of jaundice), kidney disease, gastroenterology, respiratory disease, cardiovascular disease (including ischemic heart disease), endocrinology, neurology, immunology, or hematology (specifically, current agranulocytosis with an absolute neutrophil count of <500 mm3)
• History of narrow-angle glaucoma.
• History of allergic reaction to the medication (s) of the study.
• Substance dependency (with the exception of nicotine and caffeine) according to the DSM-IV within the last month.
• Remoxipride treatment within 6 months (180 days) prior to Visit 2.
• Any other medication that primarily acts on the central nervous system that is not specified in Section 3.8.
• History of cardiac arrhythmia, decompensated heart failure, sinus node syndrome, or other disorders in which a decrease in cardiac output or peripheral vascular resistance may place the patient in a situation of medical risk, including acute myocardial infarction, unstable angina pectoris and marked hypotension or ECG abnormalities considered clinically significant by the researcher or the appropriate representative designated by the researcher that could have clinical implications regarding the patient´s participation in the present study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The efficacy scales will be administered in Visit 1 in order to verify the eligibility criteria, Positive and Negative Symptom Scale (PANSS), Brief Psychiatric Evaluation Scale (BPRS) extracted from the PANSS Scale, Global Clinical Severity Impression Scale (CGI-S), Global Clinical Improvement Impression Scale (CGI-I)<br>Measure:Improvement of patients on the PANSS, BPRS, CGI-S and CGI- Scales<br>Timepoints:After treatment<br>