None listed
Conditions
Interventions
Group 1 Type of group
Olanzapine 10-20 mg / day daily for 28 weeks
Group name:Group 2 Type of group
Ziprasidone 80-160 mg / day daily for 28 weeks
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
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
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 ( 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 • Individuals who have completed or who have previously withdrawn from this study.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) Measure:Improvement of patients on the PANSS, BPRS, CGI-S and CGI- Scales Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Scores of the classification scale in all post-baseline visits. Measure:All post-baseline data corresponding to the CGI Improvement Scale Timepoints:all post-baseline visits. ; Outcome name:Difference between the baseline and the last observation under the active study medication (LOCF change scores). Measure:Change from the baseline to the last observation; Total PANSS and sub-scales, total BPRS (extracted from the PANSS Scale) and sub-scales MADRS, HAM-A, CGI-S Timepoints:After treatment ; Outcome name:A reduction of at least 30% from the baseline to the evaluation parameter (endpoint). Time from the random assignment to the first achievement of response criteria. Cumulative percentage of patients who responded at each reduction level. Measure:Response based on the total PANSS Timepoints:After treatment ; Outcome name:Index of relapse in patients who responded. Time to relapse Measure:Relapse based on the total PANSS Timepoints:Time to relapse ; Outcome name:Exacerbation index in patients who responded. Exacerbation times Measure:Symptom exacerbation based on total PANSS and CGI-S Timepoints:8 weeks | — |
Outcome results
None listed