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van CCT (UK)

Raloxifene Augmentation in Patients with a Schizophrenia spectrum Disorder

- candidate number23628
- NTR NumberNTR5672
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jan-2016
- Secondary IDs2015-004483-11 EudraCt
- Public TitleRaloxifene Augmentation in Patients with a Schizophrenia spectrum Disorder
- Scientific TitleRaloxifene Augmentation in Patients with a Schizophrenia spectrum Disorder to reduce symptoms and improve cognition
- hypothesisDaily treatment with raloxifene 120 milligrams (mg) in addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases social and personal functioning, reduces health care costs, as compared to placebo.
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Schizoaffective disorder, Schizophreniform disorder, Psychosis
- 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- 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 ( - 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;
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate31-dec-2018
- Target number of participants148
- InterventionsPatients will be randomized 1:1 to either 120mg raloxifene or placebo daily for a period of 12 weeks. Identical tablets will be administered.
- Primary outcomePrimary outcomes are change in symptom severity, measured with PANSS and BNSS and changes in cognition, measured with BACS.
- Secondary outcomeSecondary 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).
- Timepoints- Baseline
- 2 weeks of treatment (phone call)
- 6 weeks of treatment
- 12 weeks of treatment (end of treatment)
- 6 month follow-up after end of treatment
- 1 year follow-up (phone call)
- 2 year follow-up (phone call)
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsHeringa, Sophie M., Marieke JH Begemann, Angelique J. Goverde, and Iris EC Sommer. "Sex hormones and oxytocin augmentation strategies in schizophrenia: A quantitative review." Schizophrenia research (2015).
- Brief summaryPatients with a schizophrenia spectrum disorder experience substantial impairments in multiple domains of everyday life, including the ability to maintain social relationships, sustain employment, and live independently. These problems often persist, even after successful treatment of psychosis. Currently, no consistent evidence exists for the efficacy of interventions to reduce cognitive and negative symptoms, while in fact these are the factors that determine functioning to a great extent.

Premenopausal women with schizophrenia have less psychotic and negative symptoms, and better cognitive and social functioning, in comparison to men and older women. This has been related to protective effects of estrogens in the brain. Administering estrogens has positive effects on psychotic symptoms, but exerts long-term side effects, especially in men.

Raloxifene is a selective estrogen receptor modulator, with a beneficial side effect profile in women and in men. It has been shown to be effective in reducing symptoms in postmenopausal women with schizophrenia. Recently, positive results were found in premenopausal women and in men. It is important to replicate these results in an independent sample and to investigate the effects of raloxifene on functioning.

Hypotheses: Daily treatment with raloxifene 120 milligrams (mg) in addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases social and personal functioning, reduces health care costs, as compared to placebo.
- Main changes (audit trail)
- RECORD19-jan-2016 - 20-mrt-2016

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