schizophrenia, schizophreniform disorder, schizoaffective disorder and psychotic disorder NOS
Conditions
Interventions
Patients will be randomized 1:1 to either 120mg raloxifene or placebo daily for a period of 12 weeks. Identical tablets will be administered.
Sponsors
UMC Utrecht
Eligibility
Inclusion 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; - Age over 18 years. 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
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; - Use of levothyroxine or other thyromimetics; - Hypertriglyceridemia (triglycerides > 3 times the upper limit of normal (ULN)); - Liver function or enzyme disorders (serum bilirubin, alkaline phosphatase (AF), gamma-glutamyl transpeptidase (ã - 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are change in symptom severity, measured with PANSS and BNSS and changes in cognition, measured with BACS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are changes in personal and social performance (measured with PSP), change in severity of thought disorder (measured with TALD), quality of life (measured with EQ-5D), use of healthcare and non-healthcare resources, comorbid depression (measured with BDI), cognitive control (measured with a Stroop Test), language production (measured by analyzing speech samples), hormonal and inflammatory biomarkers, and psychophysiological parameters of basic information processing (i.e. P300 and N100, measured using electroencephalography). | — |
Outcome results
None listed