Bazedoxifene -Treatment for Women With Schizophrenia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorThe Alfred
About this trial
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 criteria
Qualifiers
Physically well.
A current DSM-V diagnosis of schizophrenia or related disorder.
18- 65 years
Able to give informed consent.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bazedoxifene Acetate
- Placebo
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Alfred
Lead sponsor
Monash University
Collaborator
Source ClinicalTrials.gov