Raloxifene augmentation in patients with a schizophrenia spectrum disorder to reduce symptoms and improve cognitio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 95

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;
- 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.

Exclusion Criteria

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this trial is to investigate the beneficial effect of<br /><br>raloxifene as compared to placebo when given for twelve weeks in addition to<br /><br>antipsychotic medication. We expect to find lower severity of psychotic and<br /><br>cognitive symptoms as measured with the Positive And Negative Symptom Scale<br /><br>(PANSS) and the Brief Assessment of Cognition in Schizophrenia (BACS) over the<br /><br>course of 12 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are changes in negative symptoms (measured with BNSS),<br /><br>changes in personal and social performance (measured with PSP), change in<br /><br>severity of thought disorder (measured with TALD), quality of life (measured<br /><br>with EQ-5D), use of healthcare and non-healthcare resources, comorbid<br /><br>depression (measured with BDI), cognitive control (measured with a Stroop<br /><br>Test), language production (measured by analyzing speech samples), DNA-profiles<br /><br>and hormonal and inflammatory biomarkers. </p><br>