Bazedoxifene -Treatment for Women With Schizophrenia

Launched by THE ALFRED · Oct 1, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called bazedoxifene to see how it can help women with schizophrenia and related disorders. Bazedoxifene is a type of medication that works on estrogen receptors in the body, and the study aims to find out if adding it to the standard antipsychotic medications that participants are already taking can improve their symptoms. The trial is currently looking for women aged 18 to 65 who have a confirmed diagnosis of schizophrenia or similar conditions and who are in stable health. To participate, they must meet certain criteria, such as having specific scores on a psychiatric assessment and a history of normal health screenings.

If eligible, participants will be part of a double-blind study, meaning neither they nor the researchers will know who receives the actual medication and who receives a placebo (a non-active treatment). This helps ensure the results are reliable. Women who have certain medical conditions, are pregnant or breastfeeding, or have specific recent health issues may not be able to participate. Overall, this trial aims to explore a potential new treatment option for women struggling with schizophrenia, offering hope for better management of their symptoms.

Gender

FEMALE

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 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.