EUCTR2017-004984-11-FR进行中（未招募）1 期
Study of maintenance of the efficacy and adverse effects of pharmacological treatments in sex offenders with paraphilia ESPARA - ESPARA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
入选标准
- •1.) Sexual offenders (sexual offense or assault including exhibitionism, rape, sexual touching, incest, possession of video material of a child pornography nature) (severity level 2 to 6 as recommended by the WFSBP)
- •2.) Men with paraphilic disorders (DSM-5 criteria described in Chapter 4)
- •3.) Receiving pharmacological treatments, either SSRI or antiandrogenic treatments. Levels 2-6 of severity of paraphilic disorders (DSM-5 criteria) will be included (see Chapter 2 for definition of 6 levels, WFSBP recommendations for pharmacological treatment of paraphilias). According to current recommendations, patients with level 2 and 3 severity should receive SSRIs and they above level 3 severity should receive antiandrogens, but the treatment decision is made by the psychiatrist in charge of the patient before the inclusion in this study (design of the naturalistic study).
- •4.) Aged 18 to 65 years
- •5.) Patients 100% covered by their medical cover for the treatment of their paraphilia
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.) Subjects under the age of 18 or over 65
- •2.) Subject in prison (whatever the reason)
- •3.) Female subjects
- •4.) Subjects under guardianship
- •5.) Subjects who have committed a sexual offense and who do not meet the criteria for a paraphilic disorder (eg rape of a spouse or friend under the influence of alcohol)
- •6.) No registration with the social security system
- •7.) Refusal of consent
- •8.) Subjects concomitantly receiving SSRIs and antiandrogens at baseline
- •9.) Contraindications or allergies to the treatments used
研究者
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