Clinical trial NCT03495414: Neurobiological Underpinnings to Hypersexual Disorder
Official title: Neurobiologisk Bakgrund Till Hypersexuell Störning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersexuality
Hypersexual Disorder
Compulsive Sexual Behavior
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)
First posted: 2018-04-12
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brain activity
timeFrame: acquired during brain imaging experiment (MRI scan day)
measure: Anatomical brain measures
timeFrame: Acquired during brain imaging experiment (MRI scan day)
Secondary outcomes:
measure: Resting state fMRI
timeFrame: Acquired during fMRI experiment (MRI scan day)
measure: Diffusion MRI
timeFrame: Acquired during fMRI experiment (MRI scan day)
measure: Reaction times
timeFrame: Acquired during fMRI experiment (MRI scan day)
measure: Raven Progressive Matrices (cognitive task)
timeFrame: Acquired at brain MRI assessment day, or as close to this day as possible.
measure: Balloon Analogue Risk Task (cognitive task)
timeFrame: Acquired at brain MRI assessment day, or as close to this day as possible.
measure: Stop Signal Task (cognitive task)
timeFrame: Acquired at brain MRI assessment day, or as close to this day as possible.
measure: MADRS-S (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: ASRS (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: AUDIT (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: DUDIT (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: EQ-5D (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: 4-item Kinsey-scale (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: HDSI (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: SCS (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: HBI (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: SIS/SES (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: HADS (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: GAD (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: BRSI-SE (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: RAADS (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: SDI (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: BIS-11 (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: BIS/BAS (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: Sexual Behavior (questionnaire)
timeFrame: Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
measure: fMRI experience rating (questionnaire)
timeFrame: Assessed right before and after MRI scan
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital (ANOVA)
Study officials:
References: