An observational study in Hypersexuality, Hypersexual Disorder and Compulsive Sexual Behavior, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Karolinska Institutet · Observational
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.
22 studies on the registry are indexed under Compulsive Sexual Behavior Disorder; 8 are open to participants now.
Browse Compulsive Sexual Behavior Disorder studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Controls will be physically and psychologically healthy and will show no indication of clinical hypersexuality.
Other: Brain Imaging · Other: Cognitive testing · Other: Psychometric · Other: 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.
Other: Brain Imaging · Other: Cognitive testing · Other: Psychometric · Other: Blood test
* 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).
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).
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.
Brain activity
Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.
Time frame: acquired during brain imaging experiment (MRI scan day)
Anatomical brain measures
Measures for brain morphology (regional cortical volume, thickness, surface area, and subcortical volumes)
Time frame: Acquired during brain imaging experiment (MRI scan day)
Resting state fMRI
Functional connectivity
Time frame: Acquired during fMRI experiment (MRI scan day)
Diffusion MRI
Structural connectivity
Time frame: Acquired during fMRI experiment (MRI scan day)
Reaction times
Response reaction times during fMRI task
Time frame: Acquired during fMRI experiment (MRI scan day)
Raven Progressive Matrices (cognitive task)
Objective measures for intelligence
Time frame: Acquired at brain MRI assessment day, or as close to this day as possible.
Balloon Analogue Risk Task (cognitive task)
Objective measures for impulsivity/risk-taking
Time frame: Acquired at brain MRI assessment day, or as close to this day as possible.
Stop Signal Task (cognitive task)
Objective measures for inhibitory control
Time frame: Acquired at brain MRI assessment day, or as close to this day as possible.
MADRS-S (questionnaire)
Montgomery Asberg Depression Rating Scale
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
ASRS (questionnaire)
Adult ADHD Self-Report Scale
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
AUDIT (questionnaire)
Alcohol Use Disorders Identification Test
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
DUDIT (questionnaire)
Drug Use Disorders Identification Test
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
EQ-5D (questionnaire)
General Health information
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
4-item Kinsey-scale (questionnaire)
Sexual Orientation Dimension
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HDSI (questionnaire)
Hypersexual Disorder Screening Inventory
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SCS (questionnaire)
Sexual Compulsivity Scale
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HBI (questionnaire)
Hypersexual Behavior Inventory
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SIS/SES (questionnaire)
Sexual Inhibition/Excitation Scale
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HADS (questionnaire)
Hospital Anxiety and Depression Scale
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
GAD (questionnaire)
General Anxiety Disorder scale
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BRSI-SE (questionnaire)
Bem Sex Role Inventory
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
RAADS (questionnaire)
Ritvo Autism Asperger Diagnostic Scale
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SDI (questionnaire)
Sexual Desire Inventory
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BIS-11 (questionnaire)
Barratt Impulsiveness Scale
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BIS/BAS (questionnaire)
Behavioral Inhibition/Activation System
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Sexual Behavior (questionnaire)
Frequency of pornography consumption and sexual encounters.
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
fMRI experience rating (questionnaire)
Ratings of emotions experienced in context of the fMRI task, incl. craving/desire, stimuli induced sexual arousal.
Time frame: Assessed right before and after MRI scan
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Dec 2021, 44 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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