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: 19.0Level: LLTClassification code 10039635Term: Schizophrenia schizoaffectiveSystem Organ Class: 100000004873; MedDRA version: 19.0Level: LLTClassification code 10039632Term: Schizophrenia NOSSystem Organ Class: 100000004873; MedDRA version: 19.0Level: LLTClassification code 10039648Term: Schizophreniform illnessSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-26
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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;
- 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-hormonal contraceptive (intrauterine device, cervical cap, condom, 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.
- 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;
- Use of levothyroxine or other thyromimetics;
- 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, 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:
- Pregnancy or breast feeding;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified