None listed
Conditions
Brief summary
Despite advances in the treatment of schizophrenia, pharmacotherapy remains sub-optimal, and the prognosis for many patients is poor. Estradiol has a positive role in the treatment of psychosis symptoms and cognitive deficits seen in people with schizophrenia, but it has become clear that long-term use of estradiol with progesterone may have associated increased risks of breast and other cancers. Bazedoxifene, a third generation Selective Estrogen Receptor Modulator (SERM), appears to be safer with respect to long term use than older SERMs, has additional actions on the glucocorticoid receptor, and together this different pharmacology speculatively has greater potential than other SERMs to impact favorably on both psychosis symptoms and cognition in men and women with schizophrenia. This study will test 100 men to determine if bazedoxifene, as an adjunctive hormone modulator, is effective for positive and cognitive symptoms of schizophrenia. We hypothesise that bazedoxifene will significantly reduce psychopathology and will significantly improve cognition.
Interventions
Bazedoxifene capsule dosed at 40 mg (once daily) for 12 weeks. We only dispense medication fortnightly and ask for any unused medication to be returned. Adherence is monitored through follow up telephone calls on a fornightly or weekly basis.
Sponsors
Monash University Foundation
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
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 and a score of 4 (moderate) or more on two or more of the following PANSS items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness. • Stable psychotropic medication for previous 4 weeks • 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). • Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill. • Planned changes to psychotropic medication or psychotherapy regimen.
Outcome results
None listed