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临床试验/NCT03495414
NCT03495414已完成不适用

Neurobiologisk Bakgrund Till Hypersexuell Störning

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Brain activity

研究概览

简要总结

Hypersexual Disorder (HD), sometimes called "sexual addiction", is a disorder with intense sexual desires and psychological preoccupations that lead to out-of-control sexual activities with severe consequences. HD is related to higher risks of HIV infection and an important risk factor for committing sexual crimes. The prevalence of HD is 3-6% of the general population, thus, a significant burden for society. The neurobiological mechanisms behind HD are still unknown, and there is still a great need for causal treatments.

This study is aimed at identifying neurobiological and psychological mechanisms underlying HD as a basis for treatment development. The overall goal is to improve mental health, quality of life, diagnosis and treatment options for affected individuals, and to reduce the impact HD can have on society. Patients with HD will be recruited at Karolinska University Hospital in close collaboration between endocrinologists, psychologists, psychiatrists, and brain researchers at Karolinska Institutet. Cases and healthy controls will undergo brain scans (MRI), psychological and blood tests to quantify neurobiological, cognitive, and behavioral aspects of HD.

This study is directly integrated into clinical practice, can identify important targets for interventions and factors predicting treatment outcomes. This study is essential for a better understanding of HD, the improvement of treatments, and can have significant impact on the prevention of HIV infections and sexual crimes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • At least 18 years of age,
  • Fluent in the Swedish language
  • Patients will meet diagnostic criteria for hypersexual disorder and will not have started with any psychotherapy or psychological treatment.
  • Controls will be physically and psychologically healthy, and show no indication of clinical hypersexuality

排除标准

  • For both patients and controls any reported medical or clinical condition known to affect brain structure and function, test performance, or associated with risks for the MRI environment will be exclusionary. The investigators will exclude for the following:
  • Severe neurological/psychiatric diseases or conditions (e.g., major depression, bipolar disorder, ADHD, autism, anxiety/panic disorder, obsessive compulsive disorder, personality disorder, Parkinson's disease, epilepsy, PTSD/chronic stress/burnout syndrom, Alzheimer's disease)
  • Gender identity disorder/gender dysphoria
  • Chronic pain conditions
  • Impared vision, or other vision problems that cannot be corrected with MR-safe equipment.
  • Hearing impairments, or problems with other senses
  • History of severe brain damage/injuries
  • Claustrophobia
  • Having metal implants, a pacemaker, metallic braces or other MRI contra-indications
  • Alcohol/drug dependence/abuse, eating disorder, pathological gambling, during the past 6 months.
  • HIV and Hepatitis C/B, if the condition is untreated or virus levels detectable.
  • Untreated endocrinologic diseases
  • Medication: bensodiazepine, antipsychotics, mood stabilizers, centrally acting sympathicomimetics, SSRI (if use started less than 3 months ago). Any medication or pharmaceutical drug that interferes with sex hormone production or metabolism, i.e. ketoconazol, cyproteronacetate, spironolactone and similar drugs.
  • Note: There is a potentially higher prevalence of comorbidities and medication use in patients. To facilitate recruitment and study completion, the investigators may include subjects that report specific conditions at the discretion of the principle investigator. In those cases, corresponding information will be recorded in order to control for potential confounders.

结局指标

主要结局

Brain activity

时间窗: acquired during brain imaging experiment (MRI scan day)

Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.

Anatomical brain measures

时间窗: Acquired during brain imaging experiment (MRI scan day)

Measures for brain morphology (regional cortical volume, thickness, surface area, and subcortical volumes)

次要结局

  • Reaction times(Acquired during fMRI experiment (MRI scan day))
  • Raven Progressive Matrices (cognitive task)(Acquired at brain MRI assessment day, or as close to this day as possible.)
  • Stop Signal Task (cognitive task)(Acquired at brain MRI assessment day, or as close to this day as possible.)
  • EQ-5D (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • SIS/SES (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • RAADS (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • Resting state fMRI(Acquired during fMRI experiment (MRI scan day))
  • Balloon Analogue Risk Task (cognitive task)(Acquired at brain MRI assessment day, or as close to this day as possible.)
  • AUDIT (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • Diffusion MRI(Acquired during fMRI experiment (MRI scan day))
  • MADRS-S (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • ASRS (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • BRSI-SE (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • fMRI experience rating (questionnaire)(Assessed right before and after MRI scan)
  • DUDIT (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • HDSI (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • 4-item Kinsey-scale (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • SCS (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • HBI (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • GAD (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • HADS (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • Sexual Behavior (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • SDI (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • BIS-11 (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)
  • BIS/BAS (questionnaire)(Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Abé

Assistant Professor

Karolinska Institutet

研究点 (1)

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