NCT04113993 Bazedoxifene -Treatment for Women With Schizophrenia
| NCT ID | NCT04113993 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Alfred |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2019-10-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2019-10-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04113993 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04113993 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04113993 currently recruiting?
Yes, NCT04113993 is actively recruiting participants. Contact the research team at Anthony.decastella@monash.edu for enrollment information.
Where is the NCT04113993 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT04113993 clinical trial?
NCT04113993 is sponsored by The Alfred. The trial plans to enroll 160 participants.
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