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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.
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 in the treatment of psychosis symptoms and cognitive deficits seen in people with schizophrenia. However, with the longer-term work from studies such as the Women's Health Initiative (1), it has become clear that long-term use of estradiol with progesterone may have associated increased risks of breast and other cancers. Hence, we began working with the Selective Estrogen Receptor Modulator - raloxifene, which appears to be safer for longer term use with respect to the development of breast and other cancers. Building on our and others work, raloxifene used as an adjunctive treatment in schizophrenia appears to produce inconsistent and varying responses in different sub-populations; gender, menopausal status, age, drug dose and delivery mode. We now propose to conduct a double-blind, randomized, placebo controlled trial of a third generation SERM - bazedoxifene - which is 4 times more selective for the alpha than the beta oestrogen receptor subtype. Bazedoxifene 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 160 women to determine if bazedoxifene, as an adjunctive hormone modulator, is effective for positive and cognitive symptoms of schizophrenia.
Bazedoxifene Acetate, Placebo
Monash Alfred Psychiatry Research Centre
Not yet recruiting
Published on BioPortfolio: 2019-10-09T09:21:39-0400
The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uteri...
The primary goal of this study is to assess the efficacy of bazedoxifene (BZA) as remyelinating agent in patients with relapsing-remitting multiple sclerosis. The investigators will utili...
This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA). About 24 sub...
The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.
: Bazedoxifene was found to be effective and well tolerated for the treatment and prevention of osteoporosis in postmenopausal women. This post-marketing surveillance study (PMSS) examined the safety ...
The response to antipsychotic treatment in schizophrenia appears to vary, and as such it has been proposed that different subtypes of schizophrenia exist, defined by treatment-response. This has not b...
Results of previous studies on the safety and efficacy of adjunctive reboxetine for schizophrenia have been inconsistent.
Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical...
An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 188.8.131.52.
A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS.
A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.
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