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Neurobiological Underpinnings to Hypersexual Disorder

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ClinicalTrials.gov Identifier: NCT03495414
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)
Information provided by (Responsible Party):
Christoph Abé, Karolinska Institutet

Brief Summary:

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.


Condition or disease Intervention/treatment
Hypersexuality Hypersexual Disorder Compulsive Sexual Behavior Other: Brain Imaging Other: Cognitive testing Other: Psychometric Other: Blood test

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Neurobiologisk Bakgrund Till Hypersexuell Störning
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Group/Cohort Intervention/treatment
Healthy Controls (HC)
Controls will be physically and psychologically healthy and will show no indication of clinical hypersexuality.
Other: Brain Imaging
  • Structural MRI (T1 weighted)
  • Diffusion Tensor Imaging (DTI)
  • resting state functional MRI (rs-fMRI)
  • functional MRI (fMRI): Brain activity will be measured in response to sexual images (visually evoked sexual arousal; processing of sexual stimuli), and importantly during a phase when these stimuli are anticipated (neural correlates of wanting and desire; reward anticipation).

Other: Cognitive testing

We will administer neuropsychological tests assessing objective measures for

  • intelligence (Ravens Matrices)
  • impulsivity and risk-taking behavior (Balloon Analogue Risk Task)
  • inhibitory control (Stop Signal Task).

Other: Psychometric
Administered questionnaires include anxiety and depression symptoms (MADRS, HADS, GAD), drug use (AUDIT, DUDIT), attention deficits (ASRS), impulsivity (BIS-11), reward seeking behavior (BIS/BAS), sexual orientation, (hyper)sexual behavior, desire and compulsivity aspects (HDSI, HBI, SCS, SDI, SIS/SES).

Other: Blood test
Blood samples will be taken for routine health assessment, measurement of sex hormonal levels, HPA-axis function test (dexamethasone suppression), and potential DNA extraction and (epi)genetic profiling.

Patients with hypersexual disorder (HD)
Patients will meet diagnostic criteria for HD as defined in the DSM-5 proposed criteria for hypersexual disorder (Kafka, 2010)
Other: Brain Imaging
  • Structural MRI (T1 weighted)
  • Diffusion Tensor Imaging (DTI)
  • resting state functional MRI (rs-fMRI)
  • functional MRI (fMRI): Brain activity will be measured in response to sexual images (visually evoked sexual arousal; processing of sexual stimuli), and importantly during a phase when these stimuli are anticipated (neural correlates of wanting and desire; reward anticipation).

Other: Cognitive testing

We will administer neuropsychological tests assessing objective measures for

  • intelligence (Ravens Matrices)
  • impulsivity and risk-taking behavior (Balloon Analogue Risk Task)
  • inhibitory control (Stop Signal Task).

Other: Psychometric
Administered questionnaires include anxiety and depression symptoms (MADRS, HADS, GAD), drug use (AUDIT, DUDIT), attention deficits (ASRS), impulsivity (BIS-11), reward seeking behavior (BIS/BAS), sexual orientation, (hyper)sexual behavior, desire and compulsivity aspects (HDSI, HBI, SCS, SDI, SIS/SES).

Other: Blood test
Blood samples will be taken for routine health assessment, measurement of sex hormonal levels, HPA-axis function test (dexamethasone suppression), and potential DNA extraction and (epi)genetic profiling.




Primary Outcome Measures :
  1. Brain activity [ Time Frame: acquired during brain imaging experiment (MRI scan day) ]
    Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.

  2. Anatomical brain measures [ Time Frame: Acquired during brain imaging experiment (MRI scan day) ]
    Measures for brain morphology (regional cortical volume, thickness, surface area, and subcortical volumes)


Secondary Outcome Measures :
  1. Resting state fMRI [ Time Frame: Acquired during fMRI experiment (MRI scan day) ]
    Functional connectivity

  2. Diffusion MRI [ Time Frame: Acquired during fMRI experiment (MRI scan day) ]
    Structural connectivity

  3. Reaction times [ Time Frame: Acquired during fMRI experiment (MRI scan day) ]
    Response reaction times during fMRI task

  4. Raven Progressive Matrices (cognitive task) [ Time Frame: Acquired at brain MRI assessment day, or as close to this day as possible. ]
    Objective measures for intelligence

  5. Balloon Analogue Risk Task (cognitive task) [ Time Frame: Acquired at brain MRI assessment day, or as close to this day as possible. ]
    Objective measures for impulsivity/risk-taking

  6. Stop Signal Task (cognitive task) [ Time Frame: Acquired at brain MRI assessment day, or as close to this day as possible. ]
    Objective measures for inhibitory control

  7. MADRS-S (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Montgomery Asberg Depression Rating Scale

  8. ASRS (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Adult ADHD Self-Report Scale

  9. AUDIT (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Alcohol Use Disorders Identification Test

  10. DUDIT (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Drug Use Disorders Identification Test

  11. EQ-5D (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    General Health information

  12. 4-item Kinsey-scale (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Sexual Orientation Dimension

  13. HDSI (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Hypersexual Disorder Screening Inventory

  14. SCS (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Sexual Compulsivity Scale

  15. HBI (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Hypersexual Behavior Inventory

  16. SIS/SES (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Sexual Inhibition/Excitation Scale

  17. HADS (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Hospital Anxiety and Depression Scale

  18. GAD (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    General Anxiety Disorder scale

  19. BRSI-SE (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Bem Sex Role Inventory

  20. RAADS (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Ritvo Autism Asperger Diagnostic Scale

  21. SDI (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Sexual Desire Inventory

  22. BIS-11 (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Barratt Impulsiveness Scale

  23. BIS/BAS (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Behavioral Inhibition/Activation System

  24. Sexual Behavior (questionnaire) [ Time Frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day ]
    Frequency of pornography consumption and sexual encounters.

  25. fMRI experience rating (questionnaire) [ Time Frame: Assessed right before and after MRI scan ]
    Ratings of emotions experienced in context of the fMRI task, incl. craving/desire, stimuli induced sexual arousal.


Biospecimen Retention:   Samples With DNA
DNA extraction is planned for potential epigenetic profiling for analysis of genes related to regulation of the HPA-axis and other relevant epigenomes.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Due to known effects on brain structure and function, gender dysphoria is an exclusionary condition in this part of the study.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be recruited through an ongoing CBT study (KAFKA_IT) at Karolinska University Hospital (ANOVA). Initial contact between patients and study coordinators will primarily be made through the phone helpline PrevenTell, designed to prevent sexual offences by targeting persons at risk. At the clinical visit patients will be evaluated in a face to face interview by trained psychologists/psychiatrists to establish psychiatric diagnoses, including the diagnosis of HD. If criteria for HD are met, patients will be informed about the present imaging study. Healthy controls from the Stockholm catchment area will be recruited through Karolinska Trial Alliance, and/or public advertisement in form of posters, online job postings and/or social media.
Criteria

Inclusion Criteria:

  • Male
  • 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

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495414


Contacts
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Contact: Christoph Abé, PhD +46 8-524 832 60 christoph.abe@ki.se

Locations
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Sweden
Karolinska University Hospital (ANOVA) Recruiting
Stockholm, Sweden, 113 64
Contact: Stefan Arver, MD, PhD    +46 (0) 8-585 868 76    stefan.arver@ki.se   
Contact: Christoph Abé, PhD    +46 (0) 8-524 832 60      
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)
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Responsible Party: Christoph Abé, Assistant Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03495414    
Other Study ID Numbers: 2017/2152-31
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No