Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT00191828
Eligibility Criteria:
Inclusion Criteria:
* All patients, previously treated with olanzapine as antipsychotic monotherapy, which have shown a weight gain with an increase of BMI \>7% (assessed during the routine visits from the beginning of antipsychotic treatment).
* Male or female subjects at least 18 and no more than 65 years of age.
* Subjects must be considered reliable.
* Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol.
* Each patient, (and a patient's legal representative if mandated by local law), must understand the nature of the study and must sign an informed consent document.
Exclusion criteria:
* Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count \<500 mm3).
* Prior treatment with any antipsychotic drugs associated to olanzapine.
* Judged clinically to be at significant suicidal or homicidal risk and/or agitated enough to necessitate use of restraints.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00191828
Study Brief:
Protocol Section:
NCT00191828