Bazedoxifene treatment for women with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of bazedoxifene, a selective estrogen receptor modulator, as an adjunctive treatment for women diagnosed with schizophrenia. Conducted as a double-blind, placebo-controlled study, participants will receive standardized antipsychotic medication alongside either bazedoxifene or a placebo. The study aims to assess the potential benefits of bazedoxifene in improving psychotic symptoms and cognitive deficits, building on previous findings regarding the role of estrogen in treating schizophrenia. The trial will include women aged 18 to 65 who meet specific diagnostic and health criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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
* Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill (excluding IUD or Hormone Implants).
* Pregnant (HCG will be measured at screening)
* Breastfeeding
* Planned changes to psychotropic medication or psychotherapy regimen.

Where it's running

• Multidisciplinary Alfred Psychiatry Research Centre
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Anthony de Castella
• Email: Anthony.decastella@monash.edu
• Phone: +61 390766564

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.