Bazedoxifene -Treatment for Women With Schizophrenia
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Schizophrenia, Schizophreniform Disorders, Schizo Affective Disorder
In brief
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.
Key facts
- Study ID
- NCT04113993
- Run by
- The Alfred
- People needed
- 160
- Starts
- 2019-10-07
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- Multidisciplinary Alfred Psychiatry Research Centre — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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