Bazedoxifene -Treatment for Women With Schizophrenia
Recruiting · NCT04113993 · Interventional (participants receive a specific treatment) · Lead sponsor: The Alfred
View the official record on ClinicalTrials.gov →Interventions studied
Bazedoxifene AcetatePlacebo
What this trial is about
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 take part
Age range
18 Years to 65 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Multidisciplinary Alfred Psychiatry Research Centre - Melbourne, Victoria, Australia