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Clinical Trials in Australia / NCT04113993
Recruiting Phase 4

Bazedoxifene -Treatment for Women With Schizophrenia

NCT04113993 · tracked via the Priya Life Science Australia tracker
Sponsor
Phase
Phase 4
Started
2019-10-07
Last updated
2026-06-03

Condition(s) studied

SchizophreniaSchizophreniform DisordersSchizo Affective Disorder

Investigational drug(s) / intervention(s)

Bazedoxifene AcetatePlacebo

Bazedoxifene Acetate: Oral Bazedoxifene dosed at 40 mg daily for 12 weeks

Placebo: Identically packaged placebo capsule daily

Study 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

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Multidisciplinary Alfred Psychiatry Research Centre Melbourne Victoria Recruiting

More The Alfred trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04113993 on ClinicalTrials.gov ↗ ← All trials in Australia