Changing the treatment of psychotic patients from Haloperidol to Olanzapine: An open-label clinical trial for assessment of Efficacy and Safety.

ELI LILLY INTERAMERICA INC.,0 sites0 target enrollmentSeptember 25, 1997

Overview

No summary available.

Registry

who.int

Start Date

September 25, 1997

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•\-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\.

•\-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.