Neurobiological Underpinnings to Hypersexual Disorder

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03495414
Collaborator
Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg) (Other)
42
1
45
0.9

Study Details

Study Description

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 Phase
  • Other: Brain Imaging
  • Other: Cognitive testing
  • Other: Psychometric
  • Other: Blood test

Study Design

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

Arms and Interventions

Arm 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) and CSBD according to ICD-11.

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.

Outcome Measures

Primary Outcome Measures

  1. Brain activity [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 [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 [Acquired during fMRI experiment (MRI scan day)]

    Functional connectivity

  2. Diffusion MRI [Acquired during fMRI experiment (MRI scan day)]

    Structural connectivity

  3. Reaction times [Acquired during fMRI experiment (MRI scan day)]

    Response reaction times during fMRI task

  4. Raven Progressive Matrices (cognitive task) [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) [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) [Acquired at brain MRI assessment day, or as close to this day as possible.]

    Objective measures for inhibitory control

  7. MADRS-S (questionnaire) [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) [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) [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) [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) [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) [Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day]

    Sexual Orientation Dimension

  13. HDSI (questionnaire) [Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day]

    Hypersexual Disorder Screening Inventory

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

    Sexual Compulsivity Scale

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

    Hypersexual Behavior Inventory

  16. SIS/SES (questionnaire) [Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day]

    Sexual Inhibition/Excitation Scale

  17. HADS (questionnaire) [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) [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) [Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day]

    Bem Sex Role Inventory

  20. RAADS (questionnaire) [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) [Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day]

    Sexual Desire Inventory

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

    Barratt Impulsiveness Scale

  23. BIS/BAS (questionnaire) [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) [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) [Assessed right before and after MRI scan]

    Ratings of emotions experienced in context of the fMRI task, incl. craving/desire, stimuli induced sexual arousal.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital (ANOVA) Stockholm Sweden 113 64

Sponsors and Collaborators

  • Karolinska Institutet
  • Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christoph Abé, Assistant Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT03495414
Other Study ID Numbers:
  • 2017/2152-31
First Posted:
Apr 12, 2018
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 6, 2022