Neurobiological Underpinnings to Hypersexual Disorder

Compulsive Sexual Behavior Clinical Trial

Official title:

Neurobiologisk Bakgrund Till Hypersexuell Störning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03495414
• Other study ID #: 2017/2152-31
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Compulsive Sexual Behavior
• Hypersexual Disorder
• Hypersexuality

Intervention

Other:
• 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).
• Cognitive 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).
• Psychometric
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 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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital (ANOVA)	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg)

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity	Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.	acquired during brain imaging experiment (MRI scan day)
Primary	Anatomical brain measures	Measures for brain morphology (regional cortical volume, thickness, surface area, and subcortical volumes)	Acquired during brain imaging experiment (MRI scan day)
Secondary	Resting state fMRI	Functional connectivity	Acquired during fMRI experiment (MRI scan day)
Secondary	Diffusion MRI	Structural connectivity	Acquired during fMRI experiment (MRI scan day)
Secondary	Reaction times	Response reaction times during fMRI task	Acquired during fMRI experiment (MRI scan day)
Secondary	Raven Progressive Matrices (cognitive task)	Objective measures for intelligence	Acquired at brain MRI assessment day, or as close to this day as possible.
Secondary	Balloon Analogue Risk Task (cognitive task)	Objective measures for impulsivity/risk-taking	Acquired at brain MRI assessment day, or as close to this day as possible.
Secondary	Stop Signal Task (cognitive task)	Objective measures for inhibitory control	Acquired at brain MRI assessment day, or as close to this day as possible.
Secondary	MADRS-S (questionnaire)	Montgomery Asberg Depression Rating Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	ASRS (questionnaire)	Adult ADHD Self-Report Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	AUDIT (questionnaire)	Alcohol Use Disorders Identification Test	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	DUDIT (questionnaire)	Drug Use Disorders Identification Test	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	EQ-5D (questionnaire)	General Health information	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	4-item Kinsey-scale (questionnaire)	Sexual Orientation Dimension	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	HDSI (questionnaire)	Hypersexual Disorder Screening Inventory	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	SCS (questionnaire)	Sexual Compulsivity Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	HBI (questionnaire)	Hypersexual Behavior Inventory	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	SIS/SES (questionnaire)	Sexual Inhibition/Excitation Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	HADS (questionnaire)	Hospital Anxiety and Depression Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	GAD (questionnaire)	General Anxiety Disorder scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	BRSI-SE (questionnaire)	Bem Sex Role Inventory	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	RAADS (questionnaire)	Ritvo Autism Asperger Diagnostic Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	SDI (questionnaire)	Sexual Desire Inventory	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	BIS-11 (questionnaire)	Barratt Impulsiveness Scale	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	BIS/BAS (questionnaire)	Behavioral Inhibition/Activation System	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	Sexual Behavior (questionnaire)	Frequency of pornography consumption and sexual encounters.	Assessed through an online platform (as close to MRI scan day), and/or at MRI scan day
Secondary	fMRI experience rating (questionnaire)	Ratings of emotions experienced in context of the fMRI task, incl. craving/desire, stimuli induced sexual arousal.	Assessed right before and after MRI scan