Raloxifene in patients with a schizophrenia spectrum disorder

Phase 1

• Conditions: schizophrenia, schizoaffective, schizophreniform disorder or psychosis not otherwhise specified (DSM-IV 295.*); MedDRA version: 20.0Level: LLTClassification code 10039635Term: Schizophrenia schizoaffectiveSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10039648Term: Schizophreniform illnessSystem Organ Class: 100000004873; MedDRA version: 20.0Level: LLTClassification code 10039632Term: Schizophrenia NOSSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-004483-11-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-22
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 154

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:
- Women 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 (e.g. intrauterine device, cervical cap, condom or diaphragm) in case of sexual intercourse during the active treatment phase and at least four weeks after end of treatment;
- Female patients with post coital uterine bleeding must have documented normal PAP smear and pelvic examination in the preceding five years;
- Female patients between the age of 52 and 75 must have a normal documented mammogram.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 154
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pre-existing cardiovascular disease;
- 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 clinical trial of medicinal product
• Study Design: Not specified