Tests bazedoxifene added to usual care for women with schizophrenia
Tests bazedoxifene alongside antipsychotic medicine in women with schizophrenia.
Plain-language title generated from the registry record
Registry title: Bazedoxifene -Treatment for Women With Schizophrenia
Key facts
- Where
- Melbourne, AustraliaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT04113993, who can take part
Where in Australia
- Multidisciplinary Alfred Psychiatry Research CentreMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Alfred
- Trial code
- NCT04113993
- Record updated
- 3 June 2026
- Original description
To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.Read full original descriptionShow less
Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial
To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.
Inclusion: Physically well; A current DSM-V diagnosis of schizophrenia or related disorder; 18- 65 years; Able to give informed consent; PANSS total score between 40 and 90; Documented normal PAP smear and pelvic examination in the preceding two years; Stable psychotropic medication for previous 4 weeks; Normal breast screen (for women aged over 40 years); IQ > 70 (as determined by the WAIS IV subtests); English language proficiency (in order to provide informed consent and complete cognitive test battery).
Exclusion: Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill (excluding IUD or Hormone Implants); Planned changes to psychotropic medication or psychotherapy regimen; Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event; Patients with a history of severe traumatic brain injury or significant neurological or unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation; Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and/or nicotine dependence); Women aged 40 or over who have not had a normal mammogram in the last 24 months; Pregnant (HCG will be measured at screening); Breastfeeding.