Neurobiological Underpinnings to Hypersexual Disorder

Completed

• Conditions: Compulsive Sexual Behavior; Hypersexuality; Hypersexual Disorder
• Interventions: Other: Brain Imaging; Other: Cognitive testing; Other: Psychometric; Other: Blood test

• Registration Number: NCT03495414
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study Start: 2018-04-01
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-12
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with hypersexual disorder (HD)	Psychometric	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.
Patients with hypersexual disorder (HD)	Blood test	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.
Healthy Controls (HC)	Brain Imaging	Controls will be physically and psychologically healthy and will show no indication of clinical hypersexuality.
Healthy Controls (HC)	Cognitive testing	Controls will be physically and psychologically healthy and will show no indication of clinical hypersexuality.
Healthy Controls (HC)	Psychometric	Controls will be physically and psychologically healthy and will show no indication of clinical hypersexuality.
Patients with hypersexual disorder (HD)	Brain Imaging	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.
Patients with hypersexual disorder (HD)	Cognitive testing	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.
Healthy Controls (HC)	Blood test	Controls will be physically and psychologically healthy and will show no indication of clinical hypersexuality.

Primary Outcome Measures

Name	Time	Method
Brain activity	acquired during brain imaging experiment (MRI scan day)	Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.
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

Name	Time	Method
Reaction times	Acquired during fMRI experiment (MRI scan day)	Response reaction times during fMRI task
Raven Progressive Matrices (cognitive task)	Acquired at brain MRI assessment day, or as close to this day as possible.	Objective measures for intelligence
Stop Signal Task (cognitive task)	Acquired at brain MRI assessment day, or as close to this day as possible.	Objective measures for inhibitory control
EQ-5D (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	General Health information
SIS/SES (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Sexual Inhibition/Excitation Scale
RAADS (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Ritvo Autism Asperger Diagnostic Scale
Resting state fMRI	Acquired during fMRI experiment (MRI scan day)	Functional connectivity
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
AUDIT (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Alcohol Use Disorders Identification Test
Diffusion MRI	Acquired during fMRI experiment (MRI scan day)	Structural connectivity
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
ASRS (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Adult ADHD Self-Report Scale
BRSI-SE (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Bem Sex Role Inventory
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.
DUDIT (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Drug Use Disorders Identification Test
HDSI (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Hypersexual Disorder Screening Inventory
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
SCS (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Sexual Compulsivity Scale
HBI (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Hypersexual Behavior Inventory
GAD (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	General Anxiety Disorder scale
BIS-11 (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Barratt Impulsiveness Scale
BIS/BAS (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Behavioral Inhibition/Activation System
HADS (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Hospital Anxiety and Depression Scale
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.
SDI (questionnaire)	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day	Sexual Desire Inventory

Trial Locations

Locations (1)

Karolinska University Hospital (ANOVA); 🇸🇪 Stockholm, Sweden