None listed
Conditions
Interventions
Study Period I: patients will be treated with haloperidol with a daily dose that should not exceed 20 mg the last two days before Visit 2.
Group name:Study group Type of group
Study Period II: patients will be treated with Olanzapine with a daily dose of 5-20mg that will be determined according to the clinical response and the absence of adverse events.
Study Period III: patients will be treated with the optimal dose of Olanzapine determined in period II until such medication is registered and commercially available or the sponsor completes the study.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: - Male or female patients, from 18 to 65 years of age in Visit 1. - Patients with pregnancy potential should be using a medically accepted method of contraception. - Each patient must have a sufficient level of understanding to be able to communicate intelligently with the doctor, the nurse or the study coordinator. - The patient must be considered reliable. They must agree to cooperate with all the tests and exams required by the protocol. - Each patient (or his or her legal representative) must understand the nature of the study and must sign the informed consent. - Patients must meet the criteria for schizophrenia, schizophreniform or schizoaffective disorder as defined in ICD-10 (F20.x, F23.2x, or F25.x). - Patients must have been treated with haloperidol for a minimum period of 4 weeks before being included in this study. - Patients must have a score on the total SAS of> 3.
Exclusion criteria
Exclusion criteria: - The patients who are lactating or in gestation. - Unstable disease, including liver, kidney, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinological, neurological, or hematological such that hospitalization could be anticipated within three months or death expected within three years. - Hypothyroidism or hyperthyroidism not corrected. - Acute angle glaucoma. - One or more seizures without a determined etiology. - Leukopenia or history of leukopenia, without clear and resolved etiology - Jaundice, hepatitis B positive surface antigen (HBsAg) or detectable IgM fraction of anti-HBc antibody. - History of severe allergies or multiple adverse reactions to drugs. - Substance abuse or dependence (alcohol or other drugs) within the past three months. - According to the researcher´s criteria, be at serious risk of suicide. - Participation in a clinical study of another investigational drug within one month (30 days) before entry into this study (Visit 1). - Any concomitant medication with primary activity in the central nervous system does not specify in Section 3.8. - Treatment with a neuroleptic agent with less than one dose interval between neuroleptic injections before Visit 1. - Previous exposure to Olanzapine. - Treatment with lithium, anticonvulsants, benzodiazepines, antidepressants (except fluoxetine), psychostimulants, - Reversible inhibitors of monoamine oxidase, reserpine, guanethidine or guanadrel within one week before visit 2. - Any patient treated with clozapine within four weeks before visit 2. - Treatment with non-reversible inhibitors of monoamine oxidase within two weeks before visit 2. - Treatment with fluoxetine within four weeks before visit 2. - Treatment with remoxipride within six months (180 days) before visit 2. - Use of anticholinergic medication as prophylaxis is prohibited. - More than 20 mg of haloperidol in the last two days before visit 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:El cambio desde el estado basal hasta el punto final en la puntuacion total de BPRS de la evaluacion del investigador. El punto final puede ser la ultima visita en el Periodo de Estudio II y/o Periodo de Estudio III. El cambio de esta puntuacion desde la estado basal hasta el punto final sera evaluado por una prueba t de Student y probara la hipotesis nula que el cambio promedio no es significativamente diferente de cero estadisticamente. Measure:Primary effectiveness criteria Timepoints:Visits 1,2,3, 4,6,8 or in the final visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:El cambio desde el estado basal hasta el punto final en la puntuacion total de PANSS de la evaluacion del investigador. El punto final puede ser la ultima visita en el Periodo de Estudio II y/o Periodo de Estudio III. El cambio de esta puntuacion desde la estado basal hasta el punto final sera evaluado por una prueba t de Student y probara la hipotesis nula que el cambio promedio no es significativamente diferente de cero estadisticamente. Measure:Secondary effectiveness criteria Timepoints:Visitas 1,2,3, 4,6,8 o en la Visita final ; Outcome name:El cambio desde el estado basal hasta el punto final en la puntuacion total de ICG de la evaluacion del investigador. El punto final puede ser la ultima visita en el Periodo de Estudio II y/o Periodo de Estudio III. El cambio de esta puntuacion desde la estado basal hasta el punto final sera evaluado por una prueba t de Student y probara la hipotesis nula que el cambio promedio no es significativamente diferente de cero estadisticamente. Measure:Secondary effectiveness criteria Timepoints:Visitas 1,2,3, 4,6,8 o en la Visita final ; Outcome name:Adverse events that emerge during treatment or those that worsened after baseline. These adverse events will be captured, using visits 1 and 2 as the baseline. Measure:Secondary safety parameter Timepoints:Throughout the study. | — |
Outcome results
None listed