EUCTR2016-002161-56-PL进行中（未招募）1 期
Towards the understanding of neuronal mechanisms of compulsive sexual behaviors - pharmacotherapy - NeM-CSM-FT
Mateusz Gola0 个研究点开始时间: 2016年8月23日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Heterosexual male = 18 years old
- •2.Signed informed consent
- •3.Perceived loss of control over one’s sexual behavior (pornography use, masturbation, partnered sexual activity, use of commercial sexual services) causing
- •4.Help/treatment seeking (psychological/psychiatric/sexological/self-help groups/spiritual counseling)
- •5.Meeting criteria of Hypersexual Disorder by Kafka (2010) – at least 4 out of 5 (A1-A5):
- •A1. Time consumed by sexual fantasies, urges or behaviors repetitively interferes with other important (non-sexual) goals, activities and obligations.
- •A2. Repetitively engaging in sexual fantasies, urges or behaviors in response to dysphoric mood states (e.g., anxiety, depression, boredom, irritability).
- •A3. Repetitively engaging in sexual fantasies, urges or behaviors in response to stressful life events.
- •A4. Repetitive but unsuccessful efforts to control or significantly reduce these sexual fantasies, urges or behaviors.
- •A5. Repetitively engaging in sexual behaviors while disregarding the risk for physical or emotional harm to self or others.
- •B.Significant personal distress or impairment in social, occupational or other important areas of functioning associated with the frequency and intensity of these sexual fantasies, urges or behaviors
- •C.These sexual fantasies, urges or behaviors are not due to the direct physiological effect of an exogenous substance (e.g., a drug of abuse or a medication)
- •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 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Concomittant mania, bipolar disorder, psychotic disorders, obsessive-compulsive disorder or cognitive impairment according to ICD-10 diagnostic criteria
- •2.Current use of any antidepressant, anxiolytic, antipsychotic or mood stabilizing medication
- •3.Current psychotherapy
- •4.History of any neurological disease
- •5.Substance abuse or pathological gambling
- •6.Medical contraindications for the use of paroxetine or naltrexone hydrochloride (according to medicinal product characteristics)
- •and (because of planned fMRI examination):
- •7.Implanted metal, electric or electronic devices (heart pacemaker, insulin pump, metal clips etc.)
- •8.Claustrophobia
- •9.Tattoos covering face area
研究者
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