Bazedoxifene -Treatment for Women With Schizophrenia
Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial
The Alfred
160 participants
Oct 7, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- Physically well.
- A current DSM-V diagnosis of schizophrenia or related disorder.
- - 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 Criteria8
- 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.
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Interventions
Oral Bazedoxifene dosed at 40 mg daily for 12 weeks
Identically packaged placebo capsule daily
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04113993