Neurobiological Underpinnings to Hypersexual Disorder

NCT03495414 | Completed

• 1 other identifier: 2017/2152-31
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersexuality; Hypersexual Disorder; Compulsive Sexual Behavior

Outcome Measures

Primary Outcomes (2)

• Brain activity

  Functional brain response (BOLD activity) upon presentation and anticipation of visual sexual stimuli.

  acquired during brain imaging experiment (MRI scan day)

• 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 Outcomes (25)

• Resting state fMRI

  Acquired during fMRI experiment (MRI scan day)

• Diffusion MRI

  Acquired during fMRI experiment (MRI scan day)

• Reaction times

  Acquired during fMRI experiment (MRI scan day)

• Raven Progressive Matrices (cognitive task)

  Acquired at brain MRI assessment day, or as close to this day as possible.

• Balloon Analogue Risk Task (cognitive task)

  Acquired at brain MRI assessment day, or as close to this day as possible.

Study Arms (2)

Healthy Controls (HC)

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 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.

Other: Brain Imaging; Other: Cognitive testing; Other: Psychometric; Other: Blood test

Interventions

Brain Imaging OTHER

* 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).

Healthy Controls (HC); Patients with hypersexual disorder (HD)

Cognitive testing OTHER

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).

Healthy Controls (HC); Patients with hypersexual disorder (HD)

Psychometric OTHER

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).

Healthy Controls (HC); Patients with hypersexual disorder (HD)

Blood test OTHER

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.

Healthy Controls (HC); Patients with hypersexual disorder (HD)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Due to known effects on brain structure and function, gender dysphoria is an exclusionary condition in this part of the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital, ANOVA, Stockholm (Stefan Arver, Katarina Görts Öberg): collaborator

Study Sites (1)

Karolinska University Hospital (ANOVA)

Stockholm, 113 64, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA extraction is planned for potential epigenetic profiling for analysis of genes related to regulation of the HPA-axis and other relevant epigenomes.

MeSH Terms

Conditions

Compulsive Sexual Behavior Disorder

Interventions

Neuroimaging; Neuropsychological Tests; Psychometrics; Hematologic Tests

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Sexual and Gender Disorders; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Clinical Laboratory Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 12, 2018
• Study Start: April 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

SE (1)