Bazedoxifene -Treatment for Women With Schizophrenia
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.
| Condition(s) | Schizophrenia, Schizophreniform Disorders, Schizo Affective Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 i |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Lead sponsor | The Alfred |
| Locations | Melbourne, Victoria, Australia |
| Start date | 2019-10-07 |
| NCT ID | NCT04113993 |
| Official listing | https://clinicaltrials.gov/study/NCT04113993 |