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OpenTrials
Completed

NCT Number: NCT03495414

Neurobiological Underpinnings to Hypersexual Disorder

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.

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Key information

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Karolinska University Hospital (ANOVA)

Stockholm, 113 64, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain Imaging

Other
  • 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).

Cognitive testing

Other

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).

Psychometric

Other

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).

Blood Test

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

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

Registry information

Official study title

Neurobiologisk Bakgrund Till Hypersexuell Störning

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2018
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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