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Neurobiological Underpinnings to Hypersexual Disorder

Neurobiologisk Bakgrund Till Hypersexuell Störning

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03495414
Enrollment
42
Registered
2018-04-12
Start date
2018-04-01
Completion date
2021-12-30
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compulsive Sexual Behavior, Hypersexual Disorder, Hypersexuality

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.

Interventions

OTHERBrain 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).

OTHERCognitive 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).

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).

OTHERBlood 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.

Sponsors

Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)
CollaboratorUNKNOWN
Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 100 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Brain activityacquired during brain imaging experiment (MRI scan day)Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.
Anatomical brain measuresAcquired during brain imaging experiment (MRI scan day)Measures for brain morphology (regional cortical volume, thickness, surface area, and subcortical volumes)

Secondary

MeasureTime frameDescription
Reaction timesAcquired 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
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
Stop Signal Task (cognitive task)Acquired at brain MRI assessment day, or as close to this day as possible.Objective measures for inhibitory control
MADRS-S (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayMontgomery Asberg Depression Rating Scale
ASRS (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayAdult ADHD Self-Report Scale
AUDIT (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayAlcohol Use Disorders Identification Test
DUDIT (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayDrug Use Disorders Identification Test
EQ-5D (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayGeneral Health information
4-item Kinsey-scale (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan daySexual Orientation Dimension
HDSI (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayHypersexual Disorder Screening Inventory
Resting state fMRIAcquired during fMRI experiment (MRI scan day)Functional connectivity
HBI (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayHypersexual Behavior Inventory
SIS/SES (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan daySexual Inhibition/Excitation Scale
HADS (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayHospital Anxiety and Depression Scale
GAD (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayGeneral Anxiety Disorder scale
BRSI-SE (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayBem Sex Role Inventory
RAADS (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayRitvo Autism Asperger Diagnostic Scale
SDI (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan daySexual Desire Inventory
BIS-11 (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayBarratt Impulsiveness Scale
BIS/BAS (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayBehavioral Inhibition/Activation System
Sexual Behavior (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan dayFrequency of pornography consumption and sexual encounters.
fMRI experience rating (questionnaire)Assessed right before and after MRI scanRatings of emotions experienced in context of the fMRI task, incl. craving/desire, stimuli induced sexual arousal.
SCS (questionnaire)Assessed through an online platform (as close to MRI scan day), and/or at MRI scan daySexual Compulsivity Scale
Diffusion MRIAcquired during fMRI experiment (MRI scan day)Structural connectivity

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026