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临床试验/ACTRN12619001471178
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

发起方
Monash University Foundation

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