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临床试验/EUCTR2005-003435-40-GB
EUCTR2005-003435-40-GB进行中(未招募)1 期

A Randomised Controlled Trial to Investigate the effectiveness of the Healthy Sexual Functioning (HSF) Module and Selective Serotonin Reuptake Inhibitor (SSRI) Medication to treat Deviant Sexual Arousal as part of the HM Prison Sex Offender Treatment Programme. - HSF-SSRI Trial

Department of Health0 个研究点目标入组 240 人开始时间: 2006年9月18日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
240

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • HSF evaluation:
  • Consent to treatment in HSF module of HM Prison sex offender treatment programme
  • Written informed consent for HSF evaluation
  • SSRI evaluation:
  • Consent to treatment in HSF module of HM Prison sex offender treatment programme
  • Written informed consent for SSRI evaluation
  • And any one of the following:
  • sexual preoccupation (clinical assessment from SARN or based on the MSI Obsession scale);
  • a compulsive aspect to their offending (clinical assessment from SARN);
  • mood state being an important contributor to their offending (clinical assessment from SARN);
  • impulsivity (clinical assessment from SARN or impulsivity score)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • HSF evaluation:
  • Urgent treatment need as assessed by the treatment manager
  • SSRI evaluation:
  • Presence of psychotic disorder or major mood disorder; epilepsy; uncontrolled seizure disorders; diabetes; major cardiac problems; severe renal failure
  • Concomitant treatment with psychoactive medication which may interact with the effects of the SSRI e.g. neuroleptic or antidepressant medication
  • Concomitant treatment with an anti-androgen
  • Concomitant treatment with an anti-coagulant
  • Current treatment, or treatment within the last 4 weeks with a SSRI
  • Previous adverse reaction to a SSRI

研究者

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