HypersexualityNCT03495414
Neurobiological Underpinnings to Hypersexual Disorder
An observational study of Hypersexuality and Hypersexual Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypersexuality, Hypersexual Disorder, Compulsive Sexual Behavior
- What is being tested?
- Brain Imaging, Cognitive testing and Psychometric
- How many people
- 42 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2018to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurobiologisk Bakgrund Till Hypersexuell Störning
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.
- Being tested
- Brain Imaging, Cognitive testing, Psychometric, Blood test
- Medical subject headings
- Compulsive Sexual Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain ImagingOther
- 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 testingOther
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).
PsychometricOther
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 testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls (HC) | Controls will be physically and psychologically healthy and will show no indication of clinical hypersexuality. Receives: Other: Brain Imaging; Other: Cognitive testing; Other: Psychometric; Other: Blood test | |
| 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. Receives: Other: Brain Imaging; Other: Cognitive testing; Other: Psychometric; Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity
Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.
Measured: acquired during brain imaging experiment (MRI scan day)
Anatomical brain measures
Measures for brain morphology (regional cortical volume, thickness, surface area, and subcortical volumes)
Measured: Acquired during brain imaging experiment (MRI scan day)
Secondary outcomes (25)
Resting state fMRI
Functional connectivity
Measured: Acquired during fMRI experiment (MRI scan day)
Diffusion MRI
Structural connectivity
Measured: Acquired during fMRI experiment (MRI scan day)
Reaction times
Response reaction times during fMRI task
Measured: Acquired during fMRI experiment (MRI scan day)
Raven Progressive Matrices (cognitive task)
Objective measures for intelligence
Measured: 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
Measured: Acquired at brain MRI assessment day, or as close to this day as possible.
Stop Signal Task (cognitive task)
Objective measures for inhibitory control
Measured: Acquired at brain MRI assessment day, or as close to this day as possible.
MADRS-S (questionnaire)
Montgomery Asberg Depression Rating Scale
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
ASRS (questionnaire)
Adult ADHD Self-Report Scale
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
AUDIT (questionnaire)
Alcohol Use Disorders Identification Test
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
DUDIT (questionnaire)
Drug Use Disorders Identification Test
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
EQ-5D (questionnaire)
General Health information
Measured: 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
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HDSI (questionnaire)
Hypersexual Disorder Screening Inventory
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SCS (questionnaire)
Sexual Compulsivity Scale
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HBI (questionnaire)
Hypersexual Behavior Inventory
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SIS/SES (questionnaire)
Sexual Inhibition/Excitation Scale
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HADS (questionnaire)
Hospital Anxiety and Depression Scale
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
GAD (questionnaire)
General Anxiety Disorder scale
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BRSI-SE (questionnaire)
Bem Sex Role Inventory
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
RAADS (questionnaire)
Ritvo Autism Asperger Diagnostic Scale
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SDI (questionnaire)
Sexual Desire Inventory
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BIS-11 (questionnaire)
Barratt Impulsiveness Scale
Measured: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BIS/BAS (questionnaire)
Behavioral Inhibition/Activation System
Measured: 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.
Measured: 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.
Measured: Assessed right before and after MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Apr 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersexualityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)
- Responsible party
- Principal investigator, Christoph Abé, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495414
- Sponsor's protocol ID
- 2017/2152-31
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiologisk Bakgrund Till Hypersexuell Störning
- ClinicalTrials.gov ID
- NCT03495414
- Acronym / sponsor ID
- 2017/2152-31
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls (HC) | – | Other: Brain Imaging, Other: Cognitive testing, Other: Psychometric, Other: Blood testControls will be physically and psychologically healthy and will show no indication of clinical hypersexuality. |
| Patients with hypersexual disorder (HD) | – | Other: Brain Imaging, Other: Cognitive testing, Other: Psychometric, Other: Blood testPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Healthy Controls (HC), Patients with hypersexual disorder (HD) |
| Cognitive testingWe 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 | Healthy Controls (HC), Patients with hypersexual disorder (HD) |
| PsychometricAdministered 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 | Healthy Controls (HC), Patients with hypersexual disorder (HD) |
| Blood testBlood 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. | Other | Healthy Controls (HC), Patients with hypersexual disorder (HD) |
Primary outcome
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.
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)
25 secondary outcomes
Resting state fMRI
Time frame: Acquired during fMRI experiment (MRI scan day)
Diffusion MRI
Time frame: Acquired during fMRI experiment (MRI scan day)
Reaction times
Time frame: Acquired during fMRI experiment (MRI scan day)
Raven Progressive Matrices (cognitive task)
Time frame: Acquired at brain MRI assessment day, or as close to this day as possible.
Balloon Analogue Risk Task (cognitive task)
Time frame: Acquired at brain MRI assessment day, or as close to this day as possible.
Stop Signal Task (cognitive task)
Time frame: Acquired at brain MRI assessment day, or as close to this day as possible.
MADRS-S (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
ASRS (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
AUDIT (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
DUDIT (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
EQ-5D (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
4-item Kinsey-scale (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HDSI (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SCS (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HBI (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SIS/SES (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
HADS (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
GAD (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BRSI-SE (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
RAADS (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
SDI (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BIS-11 (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
BIS/BAS (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Sexual Behavior (questionnaire)
Time frame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
fMRI experience rating (questionnaire)
Time frame: Assessed right before and after MRI scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersexuality and Hypersexual Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: acquired during brain imaging experiment (MRI scan day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.