Bazedoxifene -Treatment for Women With Schizophrenia

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Alfred
• Collaborators: Monash Health; Monash University
• Treatments: Bazedoxifene

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.