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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 65 with schizophrenia or a related disorder who take stable antipsychotic medication.
- Age
- 18 to 65 years
- Sex
- Women only
- Disease stage
- A current DSM-V diagnosis of schizophrenia or a related disorder, with a PANSS total score between 40 and 90.
- Earlier treatment
- Stable psychotropic medication for the previous 4 weeks. No estrogen, progestin or androgen hormonal therapy in the previous 4 weeks (IUD or hormone implants are not counted).
Main reasons for not taking part
- Pregnant or breastfeeding
- Past or current venous blood clot (venous thromboembolic event)
- Substance dependence in the last six months (caffeine and nicotine excluded)
- Women aged 40 or over without a normal mammogram in the last 24 months
- Planned changes to psychotropic medication or psychotherapy
Read by machine on 12 November 2026.
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, AustraliaContact: Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhDTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.