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:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT03043820
Eligibility Criteria:
Inclusion Criteria:
* A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS)
* Capable of understanding the purpose and details of the study in order to provide written informed consent;
* On a stable dose of antipsychotic medication for at least two weeks;
For female patients:
* Female patients who are sexually active must be willing and capable to use a non-estrogenic contraceptive (intrauterine device, cervical cap, condom or diaphragm) in case of sexual intercourse for the complete duration of the study;
* Female patients with post coital uterine bleeding must have documented normal PAP smear and pelvic examination in the preceding two years.
Exclusion Criteria:
* Pre-existing cardiovascular disease;
* History of thrombo-embolic events;
* History of breast cancer;
* Familial tendency to form blood clots (such as familial factor V Leiden);
* Use of vitamin K antagonists;
* Use of cholestyramine or other anion exchange resins;
* Hypertriglyceridemia (triglycerides \> 3 times the upper limit of normal (ULN));
* Liver function or enzyme disorders (serum bilirubin, alkaline phosphatase (AF), gamma-glutamyl transpeptidase (γ - GT), aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) \> 3 times the ULN as measured at baseline);
* Severe kidney failure (eGFR \<30 ml/min as measured at baseline);
* Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet in the past three months.
For female patients:
* Abnormality observed during physical breast examination;
* Pregnancy or breast feeding;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03043820
Study Brief:
Protocol Section:
NCT03043820