ACTRN12619001471178尚未招募2 期
Bazedoxifene – A New Selective Estrogen Receptor Modulator Treatment for Men with Schizophrenia: a double-blind, randomized, placebo controlled trial
Monash University Foundation0 个研究点目标入组 100 人开始时间: 2019年10月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- Male
入选标准
- •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)
排除标准
- •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.
研究者
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