Raloxifene augmentation in patients with a schizophrenia spectrum disorder to reduce symptoms and improve cognition - Raloxifene Augmentation in Patients with a Schizophrenia spectrum Disorder

Psychiatrie0 个研究点目标入组 95 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- 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;
•- Use of antipsychotic medication and being on a stable dose of antipsychotic
•medication for at least two weeks;
•- Age over 18 years.,
•For female patients:
•- Female patients of childbearing potential (WOCBP; i.e. fertile, following
•menarche and until becoming post-menopausal unless permanently sterile after
•hysterectomy, bilateral salpingectomy and bilateral oophorectomy) 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 five years. If no documented
•PAP smear is present, female patients with post coital uterine bleeding must be
•willing to undergo a PAP smear .
•- Female patients between the age of 52 and 75 must have a reported normal
•mammogram as part of the Dutch *bevolkingsonderzoek* in the preceding two
•years. In case a patient has not participated in the regular breast cancer
•screening, female patients between de age of 52 and 75 must be willing to
•undergo a mammogram.

•-Pre-existing cardiovascular disease (not including hypertension);
•-History of thrombo-embolic events;
•-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));
•-History of breast cancer;
•-Liver function or enzyme disorders (serum bilirubin, alkaline phosphatase
•(AF), gamma-glutamyl transpeptidase (* - 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 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:
•- Pregnancy or breast feeding

发起方

Psychiatrie