Status:
UNKNOWN
Bazedoxifene -Treatment for Women With Schizophrenia
Lead Sponsor:
The Alfred
Collaborating Sponsors:
Monash University
Monash Health
Conditions:
Schizophrenia
Schizophreniform Disorders
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief 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...
Detailed Description
Despite advances in the treatment of schizophrenia, pharmacotherapy remains sub- optimal, and the prognosis for many patients is poor. We have pioneered work showing that estradiol has a positive role...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04113993
Start Date
October 7 2019
End Date
December 31 2025
Last Update
November 28 2023
Active Locations (1)
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1
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3004