NCT04113993RecruitingPhase 4
Bazedoxifene -Treatment for Women With Schizophrenia
Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 26 Jun 2019
- Start date
- 7 Oct 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- The Alfred
- Diseases
- Schizophrenia
- NCT number
- NCT04113993
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 160
- From 7 Oct 2019 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Age
- Women aged 40 or over who have not had a normal mammogram in the last 24 months
Other
- Pregnant (HCG will be measured at screening)
- Breastfeeding
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multidisciplinary Alfred Psychiatry Research Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.