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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT01041092
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of schizophrenia (DSM-IV criteria)
* Postmenopausal patients. Postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) level \> 20IU/L.
* Stable doses of their current antipsychotic medication for at least a month prior to study initiation.
* Presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the PANSS scale) (Kay 1987)
* Patients have to give written informed consent to participate in the study.
Exclusion Criteria:
* Patients with a substance abuse/dependence diagnosis in the previous six months.
* Mental retardation.
* Endocrine abnormalities, acute or chronic liver disease, impaired kidney function.
* History of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident.
* Patients taking hormone replacement therapy.
* Patients taking mood stabilizer medication that cannot be discontinued.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT01041092
Study Brief:
Protocol Section:
NCT01041092