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
This study is testing if adding bazedoxifene to regular antipsychotic medication can help women with schizophrenia feel better and think more clearly.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | The Alfred Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT04113993 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 65 with a current diagnosis of schizophrenia or related disorders who are physically well and able to provide informed consent.
Not a fit: Patients with significant neurological conditions, severe traumatic brain injury, or those with known hormonal axis abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing schizophrenia symptoms in women.
How similar studies have performed: Previous studies have shown mixed results with similar approaches using other selective estrogen receptor modulators, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 and a score of 4 (moderate) or more on two or more of the following PANSS items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness. * Documented normal PAP smear and pelvic examination in the preceding two years. * Stable psychotropic medication for previous 4 weeks * Normal breast ultrasound * 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. * Pregnant (HCG will be measured at screening) * Breastfeeding * Planned changes to psychotropic medication or psychotherapy regimen.
Where this trial is running
Melbourne, Victoria
- Monash Alfred Psychiatry Research Centre — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Anthony de Castella, Applied Scince
- Email: Anthony.decastella@monash.edu
- Phone: +61 390766564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.