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:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT00690235
Eligibility Criteria:
Inclusion Criteria:
* Volunteers will be males or females 18-65 yrs of age with a diagnosis of schizophrenia or schizoaffective disorder who have a history of significant weight gain with olanzapine or clozapine administration.
* Volunteers will have a current BMI=\>27 but equal to or less than 40.
* Volunteers will have been taking a stable dose (less than 10% dose change) of clozapine or olanzapine or at least two months prior to study start.
* Volunteers will be willing and able to participate in the subcutaneous administration training week prior to study start.
* Able and willing to give informed consent.
Exclusion Criteria:
* Clinically significant abnormal pre-admission vital signs, positive HIV, or clinical laboratory evaluations, in which the principal investigator deems the subject-volunteer ineligible for the study
* Positive results for infectious diseases and sexually-transmitted diseases will be reported according to the Texas Department of State Health and Texas Administrative Code rules and guidelines
* Any patient with current diabetes mellitus, even if caused by antipsychotic use .
* Patients with active liver disease requiring current treatment. Positive hepatitis C volunteers will only be excluded if they have active liver disease or they have enzyme values are two times the upper limit of normal.
* Any patients with medical disorders that are not properly controlled by medications.
* Pregnant women or women who are breast feeding.
* Patients concomitantly treated with another conventional or second generation antipsychotic medication or with any other anti-obesity drug.
* Mental capacity is limited to the extent that the patient cannot understand the nature of the study along with its risks and benefits.
* Subjects with a high risk of suicide since there is a potential that the study medication will lower the subject's glucose levels.
* Any patient judged by the principal investigator to be inappropriate for the study.
* Known hypersensitivity to study medication or its components
* Non-English speaking
* The clinical assessments that will be used are not available in valid and reliable forms for non-English speaking populations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00690235
Study Brief:
Protocol Section:
NCT00690235